Phase 1
Completed N=50
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT02088697 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Peak Plasma Concentration (Cmax) of Sertraline — 28.3; 28.8 ng/mL
Summary
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration (Cmax) of Sertraline |
28.3; 28.8 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline |
835; 856 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02088697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.