<안전성․유효성 심사관련 제출자료목록>

○ 관련규정 : 의약품등의안전성․유효성심사에관한규정 (식품의약품안전청고시 제2007-30호, 2007.5.25.) 제2조제1항제1호 [별표1] 1. 화학구조 또는 본질조성이 전혀 새로운 신물질 의약품

자료번호 구분	1	2	3		4								5			6		7	8
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2. 제출여부	○	○	○	○	○	○	○	○	○	×	○	×	○	○	○	○	○	○	○
3. 면제사유

○ 제출자료 목록

1. 기원 또는 발견 및 개발경위에 관한 자료

2. 구조결정․물리화학적 성질 등에 관한 자료(자사기준 및 시험방법 포함)

3. 안정성에 관한 자료

3.가.	장기보존시험 또는 가속시험자료

3.가.1.	36개월 장기보존시험자료

3.가.2.	36개월 중간조건시험자료

3.가.3.	6개월 가속시험자료

3.나.	가혹시험자료

4. 독성에 관한 자료

4.가.	단회투여독성시험자료

4.가.1.	The acute toxicity of LY210448 Hydrochloride administered orally to Fischer 344 rats

4.가.2.	An acute toxicity study in Beagle dogs given a single oral dose of LY210448 Hydrochloride

4.나.	반복투여독성시험자료

4.나.1.	A chronic toxicity study and plasma level study in Fischer 344 rats maintained on diets containing Dapoxetine hydrochloride for 6 months

4.나.2.	A chronic toxicity study of Dapoxetine hydrochloride administered orally to Beagle dogs for 6 months

4.나.3.	39-week Gavage(Nasogastric) toxicity and toxicokinetic study with Dapoxetine HCl in Cynomolgus Monkeys with a 28-day recovery period

4.다.	유전독성시험자료

4.다.1.	Salmonella-Escherichia coli/Mammalian Microsomal reverse mutation assay with a confirmatory assay: Dapoxetine HCl

4.다.2.	The effect of LY210448 Hydrochloride on the induction of forward mutation at the Thymidine kinase locus of L5178Y Mouse lymphoma cells

4.다.3.	The effect of Dapoxetine hydrochloride on the In Vitro induction of chromosome aberrations in Chinese Hamster Ovary Cells

4.다.4.	The effect of Dapoxetine hydrochloride given by Gavage for 2 consecutive days on the induction of micronuclei in bone marrow of ICR Mice

4.라.	생식발생독성시험자료

4.라.1.	Placental transfer of radiocarbon following the administration of a single oral dose of 14C-Dapoxetine(LY210448) hydrochloride to pregnant CD Rats

4.라.2.	A male fertility study conducted in conjunction with a three-month subchronic study in Fischer 344 Rats maintained on diets containing LY210448 hydrochloride

4.라.3.	A 10-week female fertility study of LY210448 hydrochloride administered orally to female CD rats

4.라.4.	A developmental toxicity study of LY210448 hydrochloride administered by Gavage to CD Rats

4.라.5.	A developmental toxicity study of Dapoxetine hydrochloride administered orally to New Zealand White Rabbits

4.마.	발암성시험자료

4.마.1.	104-Week Oral Gavage Carcinogenicity Study with Dapoxetine Hydrochloride in Rats

4.마.2.	26-Week Dermal Oncogenicity Study with Dapoxetine HCl in Tg.AC Hemizygous Mice

4.사.	의존성시험자료

4.사.1.	Dependence Liability of Dapoxetine in Sprague-Dawley Rats

5. 약리작용에 관한 자료

5.가.	효력시험자료

5.가.1.	Affinity of LY210448 for receptors of neurotransmitters

5.가.2.	Inhibition of monoamine uptake by LY210448 Tartrate in synaptosomal preparations of rat brain

5.가.3.	Affinities of Dapoxetine, its racemate and the (-)-isomer for the serotonin uptake site in cortical membranes of rat brain

5.가.4.	LY210448, its racemate and the (-)-isomer as inhibitors of serotonin uptake in human platelets

5.가.5.	The Actions of Dapoxetine HCl at Dopamine 1 Receptors

5.가.6.	The Inhibition of Monoamine Uptake by Dapoxetine HCl and Metabolites

5.가.7.	The Inhibition Constant of Dapoxetine at Monoaminergic Transporters and Subtypes of the Serotonin Receptor

5.가.8.	Selective inhibition of serotonin uptake by LY210448 In vivo: Dose response and time course studies

5.가.9.	Dose-response inhibition of Ex vivo 3H-Serotonin uptake in rat hypothalamus and platelets by Dapoxetine hydrochloride

5.가.10.	Dose-response inhibition of Ex vivo 3H-Serotonin uptake in Beagle Dog hypothalamus and platelets by Dapoxetine hydrochloride

5.가.11.	Dapoxetine Hydrochloride: Multiple Dose Regimen and Pharmacodynamics

5.가.12.	Neurochemical effects of LY210448 in rats and mice

5.나.	일반약리시험자료 또는 안전성약리시험자료

5.나.1.	The Binding Activity of Dapoxetine at Receptors, Neurotransmitter, Ion Channels, and Enzymes

5.나.2.	CNS Behavioral effects of LY210448 Hydrochloride administered orally in the male CD-1 Mouse

5.나.3.	Effects of dapoxetine on the membrane K+ current IKr in HERG-transfected HEK293 cells compared to astemizole

5.나.4.	Effects of JNJ-17337697-AAC(Dapoxetine) in the isolated, spontaneously beating right atrium of the guinea-pig

5.나.5.	Electrophysiological evaluation of dapoxetine in isolated rabbit Purkinje fibers in a condition of a normal rhythm and of bradycardia

5.나.6.	Electrophysiological effect of dapoxetine in isolated, Langendorff-perfused rabbit hearts

5.나.7.	Effect on blood pressure and heart rate in conscious rats of oral LY210448 Tartrate

5.나.8.	Cardiovascular and respiratory effects fo LY210448 Hydrochloride administered intravenously to anesthetized dogs

5.나.9.	A study of the acute effects of LY210448 Hydrochloride administered orally on urine and electrolyte excretion in female Sprague-Dawley rats

5.나.10.	A study of the immune response in male CD-1 mice treated orally sith LY210448 Hydrochloride

5.다.	흡수, 분포, 대사 및 배설시험자료

5.다.1.	The Bioavailability of 14C-LY210448 in male Fischer 344 rats following the oral or intravenous administration of 14C-LY210448 Hydrochloride at 25 or 12.5 mg/kg, base weight, respectively

5.다.2.	Pharmacokinetics, Metabolism, and Excretion of [14C]-Dapoxetine Following Oral Administration to Monkeys

5.다.3.	Distribution of radiocarbon into tissues following the oral administration of 14C-LY210448 Hydrochloride to male Fischer 344 rats at 25mg/kg

5.다.4.	The In Vitro Binding of [3H] Dapoxetine Hydrochloride to Plasma Proteins from Mouse, Rat, Dog, Cynomolgus Monkey, and Human

5.다.5.	The In Vitro Protein Binding of 3H-Desmethyldapoxetine, 3H-Didesmethyldapoxetine, and 3H-Dapoxetine-N-Oxide in Mouse, Rat, Dog, Monkey, and Human Plasma

5.다.6.	Radioactive metabolite profile of urine from male Fischer 344 rats following the oral administration of 14C-LY210448 Hydrochloride at 25 mg/kg, base weight

5.다.7.	Radioactive metabolite profile of bile from male Fischer 344 rats following the oral administration of 14C-LY210448 Hydrochloride at 25 mg/kg, base weight

5.다.8.	Investigation into the Metabolic Pathway of Dapoxetine HCl in Male Human, and Male and Female Cynomologus Monkey Microsomes

5.다.9.	Further Investigation into the Metabolic Pathway of Dapoxetine HCl in Male Human, and Male and Female Cynomolgus Monkey Liver Microsomes and Plasma and NMR Identification of the Key Male Human and Male Monkey Metabolites

5.다.10.	A balance study in male CD-1 mice following the oral administration of 14C-LY210448 Hydrochloride at 25 mg/kg, base weight

5.다.11.	A balance study in male Fischer 344 rats following the oral administration of 14C-LY210448 Hydrochloride at 25 mg/kg, base weight

5.다.12.	A balance study in female Beagle dogs following the oral administration of 14C-LY210448 Hydrochloride at 15 mg/kg, base weight

5.다.13.	Characterization and Tentative Identification of Metabolites in Bile, Urine and Plasma Collected from Rats after a Single Oral Dose of [14C]-Dapoxetine

6. 임상시험성적에 관한 자료

6.가.	임상시험자료집

6.가.1.	Effect of Food on the Pharmacokinetics of 60 mg Dapoxetine HCl

6.가.2.	An Open-label Study to Assess the Mass Balance, Metabolism and Absolute Bioavailability of Dapoxetine

6.가.3.	LY210448 Hydrochloride: Study of Effect of Food on Bioavailability in Normal Volunteers

6.가.4.	Open-Label, 3-Way Crossover Study to Assess the Bioequivalence of the Capsule and Tablet Formulations of Dapoxetine HCl

6.가.5.	Open-label, 4-Way Crossover Study to Assess the Bioequivalence of Dapoxetine HCl Tablets with different particle sizes

6.가.6.	Placebo-Controlled, Double-Blind, Randomized Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapoxetine HCl in Male Subjects with Hypertension

6.가.7.	Single and Multiple Dose Pharmacokinetics of Dapoxetine

6.가.8.	Dapoxetine Hydrochloride [S (+) LY210448-HCl]: ADME of 14C-labeled Dose

6.가.9.	Effect of Age on the Pharmacokinetics of 60 mg Dapoxetine HCl

6.가.10.	Pharmacokinetics and Electrocardiographic Pharmacodynamics of  Dapoxetine HCl in Healthy Male CYP2D6 Poor and Extensive Metabolizers

6.가.11.	An Open-label study of the Pharmacokinetics of Dapoxetine in subjects with Normal or Impaired Renal Function

6.가.12.An Open-label study of the Pharmacokinetics of Dapoxetine in subjects with Normal or Impaired Hepatic Function

6.가.13.	Single- and Multiple-Dose Study to Evaluate and Compare the Pharmacokinetics of Dapoxetine Between Healthy Japanese and Caucasian Men

6.가.14.	Pharmacokinetics of Dapoxetine HCl in Chinese Male Subjects

6.가.15.	Effect of Multiple Dose Dapoxetine HCl on the Pharmacokinetics and  Pharmacodynamics of Racemic Warfarin

6.가.16.	Effect of Multiple Dose Dapoxetine HCl on Midazolam Pharmacokinetics

6.가.17.	Effect of Multiple Dose Ketoconazole on Dapoxetine Pharmacokinetics

6.가.18.	Assessment of the Tolerability and Potential Pharmacokinetic Interaction Between Fluoxetine and Dapoxetine HCl

6.가.19.	Effect of Multiple Dose Dapoxetine HCl on Omeprazole Pharmacokinetics

6.가.20.	Pharmacokinetic and Pharmacodynamic Evaluation of the Potential Interaction Between Dapoxetine HCl and Ethanol

6.가.21.	Effect of PDE5 Inhibitors on Dapoxetine Tolerability and Pharmacokinetics

6.가.22.	Effect of Multiple Dose Dapoxetine HCl on Glyburide Pharmacokinetics and Pharmacodynamics

6.가.23.	Effect of Multiple Dose Dapoxetine HCl on Desipramine Pharmacokinetics

6.가.24.	Tolerability and Safety of Dapoxetine in Combination with Tamsulosin

6.가.25.	Electrocardiographic Pharmacodynamics of Dapoxetine

6.가.26.	Pharmacokinetics and Electrocardiographic Effects of Dapoxetine Hydrochloride

6.가.27.	Placebo-Controlled, Double-blind, Randomized, Crossover Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

6.가.28.	A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

6.가.29.	A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

6.가.30.	A Phase II, Double-Blind, Randomized, Placebo-Controlled Crossover Study of the Safety and Efficacy of Dapoxetine HCl in the Treatment of Premature Ejaculation

6.가.31.	A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Subjects With Premature Ejaculation

6.가.32.	A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Withdrawal Effects of Chronic Daily and As Needed Dosing With Dapoxetine in the Treatment of Premature Ejaculation

6.가.33.	A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

6.나. 가교자료

6.나.1.	가교설명서

7. 외국의 사용현황 등에 관한 자료

8. 국내 유사제품과의 비교검토 및 당해 의약품등의 특성에 관한 자료.  끝.