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
- Conditions
- Healthy Male Adults
- Registration Number
- JPRN-jRCT2080223718
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 74
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.
- Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method