JPRN-jRCT2080223718已完成1 期
A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
研究概览
简要总结
Bioequivalence for aripiprazole was confirmed between administration of ASC-01 and concomitant administration of aripiprazole and sertraline. There were no notable differences in safety or tolerability between administration of ASC-01 and concomitant administration of aripiprazole and sertraline. There were no notable differences in safety or tolerability between administration of ASC-01 under a fasting condition and under a fed condition.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old（—）
- 性别
- Male
入选标准
- •Subject has a body mass index (BMI = body weight [kg]/height [m]2) of larger than 18.5inclusive and smaller than 25.0 kg/m2 at screening.
- •- Subject is providing consent for participation in this trial in writing prior to the start of the procedures related to this trial, and judged by the investigator or subinvestigator to be capable of observing procedures in this trial.
排除标准
- •- Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.
研究者
相似试验
已完成
1 期
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male AdultsHealthy Male AdultsNCT03342963Otsuka Pharmaceutical Co., Ltd.74
已完成
3 期
Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive DisorderMajor Depressive DisorderNCT02046564Otsuka Pharmaceutical Co., Ltd.412
已完成
不适用
Bioequivalence study of aripiprazole when administered as a 15 mg orally disintegrating tablet relative to a 15 mg commercial tablet in healthy male and/or female subjects under fasting conditioMental and behavioral disordersKCT0001677BioCore40
已完成
3 期
Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive DisorderMajor Depressive DisorderNCT00876343Otsuka Pharmaceutical Co., Ltd.586
已完成
1 期
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male SubjectsHealthy VolunteersNCT02088697Otsuka Pharmaceutical Co., Ltd.50