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

A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate 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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223718

Enrollment

Registered

2017-11-15

Start date

2017-11-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Adults

Interventions

investigational material(s) Generic name etc : ASC-01 INN of investigational material : - Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : C

As it is stated that drugs are usually given to subjects after fasting for more than 10 hours in the BE Guideline, we decided to administer IMP after 10 or more hours of fasting . Cohort 2

For the administration of IMP under a fasting condition, we decided to administer IMP after 10 or more hours of fasting by referring to the dose regimen stated in the BE Guideline as above. For the ad

ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hour

Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hour

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Bioequivalence: Cohort 1; Cmax and AUC168h of aripiprazole. Food Effect: Cohort 2; Cmax, and AUC168h of aripiprazole and sertraline	—

Secondary

Measure	Time frame
pharmacokinetics Bioequivalence: Cohort 1; Pharmacokinetic parameters of aripiprazole (tmax etc.,). Food Effect: Cohort 2; Pharmacokinetic parameters of aripiprazole and sertraline (tmax etc.,)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026