CompletedInterventionalPhase 3Updated May 21, 2018
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects | NCT02088697 | Trialant
CompletedInterventionalPhase 1Updated Jun 3, 2021
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
ClinicalTrials.gov ID
NCT02088697
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
50Actual
Last Update Posted
Jun 3, 2021Actual
Start Date
Dec 2013
Primary Completion Date
Jan 2014Actual
Completion Date
Jan 2014Actual
Brief Summary
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
Healthy Volunteers
Placebo
ASC-01
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
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.