Status:
COMPLETED
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
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Healthy Male Adults
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole ...
Eligibility Criteria
Inclusion
- Healthy male subject at the age between 20 and 40 at the time of informed consent
- Subject has a body mass index (BMI = body weight \[kg\]/height \[m\]2) of ≥18.5 and \<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.
Exclusion
- Subject has a clinically significant abnormality in physical findings at screening or in medical history that in the investigator's or subinvestigator's opinion may place the subject at risk or interfere with outcome variables including drug absorption, distribution, metabolism, and excretion.
- Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2018
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03342963
Start Date
November 21 2017
End Date
January 18 2018
Last Update
May 3 2021
Active Locations (1)
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1
Clinic of Kyusyu Region
Fukuoka, Japan