A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
- Registration Number
- NCT02088697
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
- Healthy male volunteers aged 20 to 40 years.
- Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.
Exclusion Criteria
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASC-01 placebo Placebo A single oral dose of ASC-01 Placebo (sertraline 100 mg) Sertraline tablet ASC-01 A single oral dose of sertraline tablets (sertraline 100 mg)
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of Sertraline predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
Trial Locations
- Locations (1)
Osaka Pharmacology Clinical research Hospital
🇯🇵Osaka, Japan