<안전성․유효성 심사관련 제출자료목록>

○ 관련규정 : 의약품등의 품목허가․신고심사 규정 (식품의약품안전청고시 제2008-56호, 2008.8.14.) 제2조제7초 신약, [별표1] 화학구조 또는 본질 조성이 전혀 새로운 신물질 의약품

자료번호 구분	1	2	3		4								5			6		7	8
			가	나	가	나	다	라	마	바	사	아	가	나	다	가	나
1. 제출자료	○	○	○	○	○	○	○	○	△	△	△	△	○	○	○	○	○	○	○
2. 제출여부	○	○	○	○	○	○	○	○	○	○	○	x	○	○	○	○	○	○	○
3. 면제사유	△: 개개 의약품에 따라 판단하여 제출하는 것이 무의미하거나 불가능하여 면제할 수 있는 것

1. 기원 또는 발견 및 개발경위에 관한 자료, 2. 구조결정․물리화학적 성질 및 생물학적 성질, 3. 안정성에 관한 자료(가. 장기보존시험 또는 가속시험자료, 나. 가혹시험자료), 4. 독성에 관한 자료(가. 단회투여독성시험자료, 나. 반복투여독성시험자료, 다. 생식․발생독성시험자료, 라. 유전독성시험자료, 마. 면역독성시험자료(항원성시험 및 기타 면역독성시험자료), 바. 발암성시험자료, 사. 의존성시험자료, 아. 국소독성시험자료),  5. 약리작용에 관한 자료(가. 효력시험자료, 나. 일반약리시험자료, 다. 흡수, 분포, 대사 및 배설시험자료), 6. 임상시험성적에 관한 자료(가. 임상시험자료집, 나. 가교자료), 7. 외국의 사용현황 등에 관한 자료, 8. 국내 유사제품과의 비교검토 및 당해 의약품등의 특성에 관한 자료

○ 제출자료목록

1. 기원 또는 발견 및 개발경위에 관한 자료

2. 구조결정․물리화학적 성질 및 생물학적 성질에 관한 자료

3. 안정성에 관한 자료

가. 장기보존시험 또는 가속시험자료 (PTP/HDPE bottle)

: 장기보존시험(36개월), 가속시험(6개월)

나. 가혹시험자료

4. 독성에 관한 자료

가. 단회투여독성시험자료

1) Toxicity studies of AD-5423 (I):Single-dose toxicity study in male and female rats.(90101A)

2) Toxicity studies of AD-5423(II): Single-dose oral toxicity study in male and female beagle dogs (90102A)

나. 반복투여독성시험자료

1) Toxicity studies of AD-5423 V. Thirteen-week Repeated dose oral toxicity study in male and female rats. (90103S)

2) Twenty-six-week repeated dose oral toxicity study of AD-5423 in male and female rats (JBC-93-ROCH-242)

3) Thirteen-week repeated-dose oral toxicokinetic study of AD-5423 in male and female rats (G97006)

4) Toxicokinetic study of AD-5423 and its metabolites in male and female rats treated orally with AD-5423 for 13weeks (GT0401)

5) Toxicity studies of AD-5423 VI; Thirteen-week repeated dose oral toxicity study in male and female beagle dogs (91101S)

6) Toxicity studies of AD-5423 VII; Recovery study in female beagle dogs after receiving 13-week repeated oral dose of AD-5423. (93101S)

7) 52-week toxicity study of AD-5423 by repeated oral administration in beagle dogs. (B-2190)

8) 52-week toxicity study of AD-5423 by repeated oral administration in beagle dogs.(additional study) (B-3460)

9) Toxicokinetic study of AD-5423 and its metabolites in male and female beagle dogs treated orally with AD-5423 for 13 weeks (GT0334)

10) Toxicity studies of AD-5423 IV; Four-week repeated-dose oral toxicity study in male and female beagle dogs. (91001S)

11) Recovery study in female beagle dogs after receiving 13-week repeated oral dose of AD-5423: Determination of plasma concentration of AD-5423 (O-284)

다. 생식․발생독성시험자료

- Reproductive and developmental toxicity studies of AD-5423 (6)- Toxicokinetic study of AD-5423 in rats (96101T)

- Reproductive and developmental toxicity studies of AD-5423 (7) - Toxicokinetic study of AD-5423 in rabbits (96102T)

1) 수태능 및 초기배 발생시험:

① Reproductive and developmental toxicity studies of AD-5423(4)-Fertility study in male rats (91104F)

② Reproductive and developmental toxicity studies of AD-5423(2)-Fertility study in female rats(Treatment prior to and during mating period) (91103F)

③ Reproductive and developmental toxicity studies of AD-5423(5)-Fertility study in female rats(Treatment during the early stage of pregnancy)(91105F)

④ Reproductive and developmental toxicity studies of AD-5423(1)-A preliminary fertility study in rats (Effect on female estrous cycle) (91005F)

2) 출생전후발생 및 모체기능시험:

① Study on administration of AD-5423 during the perinatal and lactation periods in rats (R-558)

② A dose range-finding study for study on administration of AD-5423 during the perinatal and lactation periods in rats (R-557)

3) 배태자 발생시험 :

① Study on oral administration of AD-5423 during the period of organogenesis in rats (R-337)

② Study on administration of AD-5423 during the period of organogenesis in rabbits (R-556)

③ A range-finding study for the study on administration of AD-5423 during period of organogenesis in rats (R-336)

④ A dose range-finding study for the study on administration of AD-5423 during period of organogenesis in rabbits (R-555)

라. 유전독성시험자료

1) 박테리아를 이용한 복귀돌연변이 시험 - Mutagenicity studies of AD-5423: I.Reverse mutation test in bacteria (90104M)

2) 포유류 배양세포를 이용한 체외 염색체이상 시험 - Mutagenicity tests of AD-5423: II. In vitro chromosomal aberration tests in CHL/IU cells (90106M)

3) 설치류 조혈세포를 이용한 체내 소핵시험 - Mutagenicity studies of AD-5423: III. Micronucleus Test in Mice (91107M)

마. 면역독성시험자료(항원성시험 및 기타 면역독성시험자료)

1) 항원성 - Antigenicity test of AD-5423) (91106N)

2) 대사물

① Mutagenicity Test of AD-9765, A Metabolite of AD-5423, Using Microorganisms (K01-3084)

② Mutagenicity Test of AD-9766, A Metabolite of AD-5423, Using Microorganisms (K01-3085)

③ Bacterial reverse mutation test of AD-9940, a metabolite of AD-5423 (SR-03216)

④ Bacterial reverse mutation test of AD-9943, a metabolite of AD-5423 (SR-03217)

⑤ Bacterial reverse mutation test of AD-5238, a metabolite of AD-5423 (SR-03215)

⑥ Chromosomal Aberration test of AD-9765, a metabolite of AD-5423, Using chinese hamster lung fibroblasts(CHL/IU cells) (K06-1065)

⑦ Chromosomal Aberration test of AD-9766, a metabolite of AD-5423, Using chinese hamster lung fibroblasts(CHL/IU cells) (K06-1066)

⑧ Chromosomal Aberration test of AD-9940, a metabolite of AD-5423, in cultured mammalian cells (SR03219)

⑨ Chromosomal Aberration test of AD-9943, a metabolite of AD-5423, in cultured mammalian cells (SR03220)

⑩ Chromosomal Aberration test of AD-5238, a metabolite of AD-5423, in cultured mammalian cells (SR03218)

3) 기타

① Study on lipidosis in beagle dogs dosed with AD-5423 for 52-weeks (96016Z)

② Investigative study on time course between elevation of vacuolated peripheral lymphocyte percentage and induction of lipidosis in female beagle dogs treated with AD-5423 (N97004)

③ Assessment of the potential of AD-5423 and its metabolites to lipidosis induction in human peripheral blood lymphocytes (N20416)

④ A study to determine potency of AD-5423 to increase percentage of peripheral vacuolated lymphocytes in rats (GZ9910)

⑤ Study on peripheral lymphocyte function in female beagle dogs given repeated oral administration of AD-5423 for 13 weeks (93003Z)

바. 발암성시험자료

1) Thirteen-week repeated dose oral toxicity study of AD-5423 administered via gavage to B6C3F1 Mice (2-W37)

2) Oncogenicity study of AD-5423 administered via gavage to B6C3F1 mice (2-W39)

3) Thirteen-week repeated dose oral toxicity study of AD-5423 administered via gavage to fischer-344 rats (2-W36)

4) Oncogenicity study of AD-5423 administered via gavage to fischer-344 rats (2-W38)

사. 의존성시험자료

① Physical dependence liability of AD-5423 in rats (97102D)

② Psychological dependence study of AD-5423 in rhesus monkeys (GD9922)

5. 약리작용에 관한 자료

가. 효력시험자료

1) Inhibitory effect of AD-5423 on the conditioned avoidance response in rats (2001-0071E)

2) Inhibitory effects of risperidone and clozapine on conditioned avoidance response in rats (2002-0159E)

3) Study of the effect of AD-5423 on methamphetamine hydrochloride-induced hyperactivity in rats  (AD5423-SR-00051)

4) Effect of AD-5423 on apomorphine-induced disruption of prepulse inhibition

5) Effects of AD-5423 on mouse models of schizophrenia

6) Catalepsy-, traction failure- and ptosis-inducing activities of AD-5423 and haloperidol (2001-0062E)

7) Effects of AD-5423 and haloperidol on plasma prolactin levels in rats (2002-0002E)

8) Ataxia- and ptosis-inducing effects of risperidone and clozapine (2002-0215E)

9) Investigation of Affinity of AD-5423 and its Metabolites for Various Receptors (AD5423-SR-00050)

10) Effects of AD-5423, AD-5238 and haloperidol on the levels of monoamines and monoamine metabolites in the rat forebrain (2001-0074E)

11) Suppressive effect of orally administered AD-5423 on apomorphine-induced gnawing in rats (2002-0211E)

12) Suppressive effect of orally administered AD-5423 on p-chloroamphetamine-induced head twitches in rats (2002-0212E)

13) Inhibitory effect of AD-5238, a metabolite of AD-5423, on the conditioned avoidance response in rats (2001-0073E)

14) Increasing effects of intravenously administered AD-5423 and AD-5238 on dopamine metabolites in the rat forebrain (2002-0213E)

15) Suppressive effects of intravenously administered AD-5423 and AD-5238 on p-chloroamphetamine-induced head twitches in rats (2002-0214E)

16) Comparative Study of 2-(4-Ethyl-1-Piperazinyl)-4-(Fluorophenyl)-5,6,7,8,9,10- Hexahydrocycloocta[b]Pyridine(AD-5423)and Haloperidol for Their Pharmacological Activities Related to Antipsychotic Efficacy and/or Adverse Side-Effects

17) Pharmacological profile of AD-5423, A Novel Antipsychotic with both potent dopamine-D2 and serotonin-S2 antagonist properties

나. 일반약리시험자료

1) Effects of AD-5423 on General Physical Condition in Rats (Study No. B031423)

2) Effects of AD-5423 and its Four Metabolites (AD-5238, AD-9765, AD-9940, AD-9943) on Action Potentials in the Isolated Guinea Pig Papillary Muscle (Study No. B031326)

3) Effects of AD-5423 and its Four Metabolites (AD-5238, AD-9765, AD-9940, AD-9943) on hERG Current (Study No. B031327)

4) Effects of AD-9766, a Metabolite of AD-5423, on Action Potentials in the Isolated Guinea Pig Papillary Muscle (Study No. B040746)

5) Effects of AD-9766, a Metabolite of AD-5423, on hERG Current (Study No. B040745)

6) Effects of AD-5423 on Respiratory Rate and Blood Gas in Conscious Dogs (Study No. B031422)

7) Follow-up Study of AD-5423: Effects of 2-week Repeated Oral Administration of AD-5423 on Electrocardiogram in Conscious Restrained Male Beagle Dogs

8) Effect of AD-5423 on Spontaneous Motor Activity in Rats (2001-0405)

9) Effect of AD-5423 on Spontaneous Motor Activity in Rats (Additional study for evaluating non-effective dose of AD-5423) (2001-0407)

10) Effect of AD-5423 on Hexobarbital-induced Sleeping Time at 30min after Oral Administration in Rats (2001-0385)

11) Effect of AD-5423 on Hexobarbital-induced Sleeping Time at 2hr after Oral Administration in Rats (2001-0386)

12) Effect of AD-5423 on Maximal Electroshock-induced Convulsion in Mice (2001-0384)

13) Effect of AD-5423 on Body Temperature in Rats (2002-0087)

14) Analgesic effect of AD-5423 in rats (hot plate method) (2001-0406)

15) Effects of AD-5423 on respiratory and cardiovascular systems in anesthetized dogs (2001-0251)

16) Effects of AD-5423 on cardiovascular system in conscious dogs (2001-0207)

17) Effects of AD-5423 on spontaneous contraction in the isolated guinea pig atrium  (2001-0252)

18) Effect of AD-5238, a metabolite of AD-5423, on spontaneous contraction in the  isolated guinea pig atrium (2001-0255)

19) Effect of AD-5690, a metabolite of AD-5423, on spontaneous contraction in the isolated guinea pig atrium (2001-0254)

20) Effect of AD-5423 on agonist-induced contractions in isolated guinea pig ileum longitudinal muscles (AD5423-SR-00003)

21) Effects of AD-5238 and AD-5690, the metabolites of AD-5423, on agonist-induced contractions in isolated guinea pig ileum longitudinal muscles (AD5423-SR-00004E)

22) Effects of AD-5423 and its metabolites, AD-5238 and AD-5690, on spontaneous contractions in isolated rabbit ileum (AD5423-SR-00005E)

23) Effect of AD-5423 on intestinal charcoal meal transit in rats (AD5423-SR-00007)

24) Effect of AD-5423 on gastric emptying in rats (30 min after administration) (2001-0348)

25) Effect of AD-5423 on gastric emptying in rats (2 hr after administration) (2001-0349)

26) Effect of AD-5423 on gastric acid secretion in rats (AD5423-SR-00006)

27) Effects of AD-5423 on urine volume and urinary electrolytes excretion in saline-loaded rats (2001-0217)

28) Effects of AD-5423 and its metabolites, AD-5238 and AD-5690, on blood coagulation in rats (AD5423-SR-00008E)

29) Effects of AD-5423 and its metabolites, AD-5238 and AD-5690, on platelet aggregation in guinea pigs (AD5423-SR-00009E)

다. 흡수, 분포, 대사 및 배설시험자료

1) 분석방법과 밸리데이션 보고서

Synthesis of [Pyridine ring-2-14C]AD-5423 (1992-0001E)

Determination of a novel anti-psychotic agent AD-5423 and its metabolites in plasma by high-performance liquid chromatography with fluorescence detection

Validation of High-performance Liquid Chromatographic and Tandem Mass Spectrometric Method for Determination of AD-5423 and Its Metabolites in Rat Brain Homogenate

Validation study on a method for determination of AD-5423 and its metabolites in rat plasma (AD5423-SR-00011E)

Long-term stability test of AD-5423 and its metabolites in rat plasma (AD5423-SR-00019E)

2) 흡수, 분포, 대사, 배설

Concentration of radioactivity in plasma and red blood cells after single intravenous or oral administration of [14C]AD-5423 to rats (1996-0063E)

Plasma and red blood cells concentrations of radioactivity after single oral administration of [14C]AD-5423 in monkeys (2002-0203)

Radioactivity concentration in plasma and red blood cells after repeated oral administrations of [14C]AD-5423 in rats (1996-0078E)

Plasma concentrations, brain distributions and urinary excretions of AD-5423 and its N-oxidized metabolites in rats after intravenous and oral dosing of AD-5423 (2002-0192E)

Plasma concentrations, brain distributions and urinary excretions of AD-5423 and its N-oxidized metabolites in dogs after intravenous and oral dosing of AD-5423 (2001-0463E)

Plasma concentrations and urinary excretions of AD-5423 and its N-oxidized metabolites in monkeys after intravenous and oral dosing of AD-5423 (2002-0030E)

Plasma Concentration and Tissue Distribution of AD-5423 in Dogs (1997-0031E)

Gastrointestinal Absorption of AD-5423 in Rats (2001-0113E)

Tissue concentrations of radioactivity after single oral administration of [14C]AD-

5423 in rats (1996-0042E)

Distribution of radioactivity after single oral administration of [14C]AD-5423 in pregnant rats (Radiometry) (1996-0126E)

Distribution of radioactivity after single oral administration of [14C]AD-5423 in pregnant rats (Whole body autoradiography) (1996-0127E)

Tissue concentrations of radioactivity after single oral administration of [14C]AD-5423 in rats (addition of time point) (2002-0201)

Whole body autoradiographic study on the distribution of radioactivity after single administration of [14C]AD-5423 in rats (1996-0041E)

Tissue distribution of radioactivity after repeated oral administrations of [14C]AD-5423 in rats (Radiometry) (2002-0202)

High Performance Liquid Chromatographic Tandem Mass Spectrometric Method for Determination of AD-5423 and Its Metabolites in Rat Brain Homogenate

Brain distribution of AD-5423 and its metabolites after single and 13-week repeated oral of AD-5423 in rats (AD5423-SR-00049)

In vitro serum protein binding of AD-5423 (2001-0329E)

Protein binding of AD-5423 and its metabolites in human serum (in vitro study) (AD5423-SR-00024)

Metabolite profile of radioactivity in milk and plasma after single oral administration of [14C]AD-5423 in lactating rats (2002-0154)

Composition of radioactive metabolites in plasma, brain and urine after oral administration of [14C]AD-5423 in rats (2001-0148E)

Profiling and structural identification of the biliary metabolites after single oral administration of [14C]AD-5423 in rats (2002-0153)

Composition of metabolites in plasma, brain and urine after oral administration of [14C]AD-5423 in dogs (2001-0021E)

Composition of metabolites in urine, plasma and brain after oral administration of [14C]AD-5423 in monkeys and characterization of urinary metabolites (2001-0214E)

Identification of the human cytochrome P450 responsible for the metabolism of AD-5423 (2002-0172)

Evaluation of species differences in AD-9765 formation in vitro (2001-0213E)

LC-MS analysis of enantiomers of 7- and 8-hydroxyl AD-5423 metabolites in plasma samples from toxicokinetics studies of rats and dogs (AD5423-SR-00047)

LC-MS analysis of enantiomers of 7- and 8-hydroxyl AD-5423 metabolites in in vitro metabolism using hepatocytes of rats, dogs and humans (AD5423-SR-00048)

Effects of AD-5423 on the drug-metabolizing enzyme system in rats (1997-0017E)

Characterization of AD-5423 metabolites formed by the in vitro metabolism of AD-5423, N-desethyl AD-5423, and AD-5423 N-oxide using rat liver S9 fraction (1999-0071E)

Isolation and characterization of the metabolites of AD-5423 in rat urine (2001-0037E)

Identification of the metabolites in brain and plasma of dogs administered AD-5423 (2001-0199E)

Tissue distribution of radioactivity after single oral administration of [14C]AD-5423 in monkeys (2002-0204)

Urinary and fecal excretion of radioactivity after repeated oral administrations of [14C]AD-5423 in rat (1996-0052E)

Milk concentration of radioactivity after single oral administration of [14C]AD-5423 in lactating rats (2002-0200)

Excretion of radioactivity in urine and feces after single administration of [14C]AD-5423 in rats (1996-0045E)

Biliary excretion and enterohepatic circulation of radioactivity after single oral administration of [14C]AD-5423 to rats with biliary fistula (1996-0044E)

Determination of AD-5423 in plasma After Single Oral Administration of Pulverized and Unpulverized AD-5423 in Rats.

Plasma concentrations of the unchanged compound after single oral doses of pulverized and unpulverized AD-5423 in rats. (AD5423-SR-00042)

다. 흡수, 분포, 대사 및 배설시험자료

1) Effect of AD-5423 on Ethanol-Induced Sleeping Time in Rats (2003-0092)

2) Interactive Effect of AD-5423 with Diazepam in Pentylenetetrazole-Induced Convulsion Test in Mice (2003-0091)

3) Inhibitory Effects of AD-5423 on human cytochrome P450 activities

4) Determination of Ki values for AD-5423 in inhibition of human cytochrome P450 activities

5) Effects of CYP3A inhibitors on AD-5423 metabolism in human liver microsomes. (2002-0217)

6) Prediction of the alteration of AD-5423 pharmacokinetics by the co-administration of drugs clinically used (2002-0285)

7) Protein binding interaction of AD-5423 and several drugs in human serum (in vitro) (1996-0077E)

6. 임상시험성적에 관한 자료

가. 임상시험자료집

1) 임상약리시험

① A phase I clinical trial of AD-5423 (AD5423-101)

② Pharmacokinetics of AD-5423 in human subjects on clinical phase 1 study (2000-0155)

③ Clinical pharmacology study of AD-5423 in healthy adult male volunteers - Assessment of the pharmacokinetics and safety of the final dosage form of AD-5423 administered as a single oral dose (AD5423-111-18)

④ Pharmacokinetic analysis in 'A clinical pharmacology study of AD-5423 in healthy male adults - an investigation of pharmacokinetics and safety for single oral doses of the final formulation' (AD-5423-SR-00028)

⑤ Clinical pharmacology study of AD-5423 in healthy adult male volunteers - Assessment of the pharmacokinetics and safety of the final dosage form of AD-5423 administered as repeated oral dose (AD5423-112-19)

⑥ Pharmacokinetic analysis in 'A clinical pharmacology study of AD-5423 in healthy male adults - an investigation of pharmacokinetic and safety for repeated oral doses of the final formulation' (AD-5423-SR-00046)

⑦ Profiling and identification of metabolites in human plasma, urine and feces after administration [14C]AD-5423. (2002-0145)

⑧ Single oral dose study of [14C]-Radiolabelled-AD-5423 to investigate Pharmacokinetics of AD-5423 in healthy male volunteers. (21219)

⑨ A phase I, single-blind, randomized, partially crossover, single ascending dose, placebo controlled clinical trial to assess the safety, tolerability and pharmacokinetics of blonanserin in healthy subjects. (M/00BLN/O1A/R)

⑩ A phase I, single-blind, randomised, parallel, placebo controlled, repeated ascending oral dose clinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of blonanserin in healthy subjects. (M/00BLN/02)

⑪ Food effect on gastrointestinal absorption of AD-5423 Tablet (AD5423-305-15)

⑫ Pharmacokinetic and statistical analysis in the study of "The effect of food intake on the plasma pharmacokinetics of AD-5423 in healthy volunteers" (2002-0226)

⑬ Clinical pharmacology study of AD-5423 in healthy adult male volunteers - An investigation between AD-5423 and erythromycin - (AD5423-113-20)

⑭ Clinical pharmacology of AD-5423 in healthy adult male volunteers - An investigation of interaction between AD-5423 and grapefruit juice (AD5423-114-21)

⑮ A phase I, randomized, open, crossover, single dose clinical trial to study the pharmacokinetics of two pharmaceutical forms of blonanserin and the influence of food on the pharmacokinetics of the compound, administered orally to healthy male subjects. (M/00BLN/03)

⑯ A phase I, open-label, randomized, two-period crossover clinical trial to assess the effect of ketoconazole on the pharmacokinetics of blonanserin in healthy volunteers. (M/00BLN/06)

⑰ A phase I, single-blind, randomized, parallel, placebo controlled clinical trial to assess the pharmacodynamics of blonanserin in healthy subjects: a PET scan study" (M/00BLN/01B)

2) 치료적탐색 임상시험

① A randomized, double-blind, placebo-controlled, parrel-group, multi-center, dose-finding clinical trial to evaluate the efficacy and safety of three doses of blonanserin(2.5mg, 5mg, 10mg) compared to haloperidol 10mg and placebo in patients with acute phase schizoprenia (M/00BLN/20)

② Evaluation of efficacy and safety of AD-5423 in schizophrenic patients (AD-5423-201-2)

③ Late phase II clinical study of AD-5423 tablet (AD-5423-202-3)

④ Plasma concentration of AD-5423 in patients (AD-5423-SR-00021)

3) 치료적확증 임상시험

① Population pharmacokinetic analysis of the AD-5423 phase 3 long-term multi-site trials. (AD5423-00016)

② Phase III Clinical Study of AD-5423 tablet - Multicenter, double-blind, haloperidol-controlled, parallel-group study - (AD-5423-301-5)

③ Long-Term Administration Study of AD-5423 tablet (Extended from the late phase II clinical study) (AD-5423-203-4)

④ Phase III Clinical Study of AD-5423 - Multicenter Long-Term Administration Study -(AD-5423-302-8)

⑤ Phase III clinical study of AD-5423 - Multicenter, long-term administration study -(AD-5423-302-12)

⑥ Phase III Clinical Study of AD-5423 - Continuation of long-term administration study requested by subjects - (AD-5423-302-13)

⑦ Determination of unchanged AD-5423 and its metabolites in human plasma in Phase III clinical study - Continuation of long-term treatment study at patient's request- (protocol No.: AD5423-302-13)

⑧ Phase III Clinical study of AD-5423 Double-blind, confirmatory study in patients with schizoprenia. (AD-5423-308-17)

⑨ 정신분열병 환자를 대상으로 블로난세린(Blonanserin)의 유효성과 안전성을 평가하는 무작위배정, 이중맹검, 리스페리돈 대조 제 3상 임상시험(BK-BLN-301)

나. 가교자료 : BK-BLN-301 가교시험보고서, 가교자료설명서

7. 외국의 사용현황 등에 관한 자료

8. 국내 유사제품과의 비교검토 및 당해 의약품등의 특성에 관한 자료