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

Study Overview
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Brief Summary
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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 3-mg tablet and two sertraline 50-mg tablets (Cohort 1). To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).

Official Title
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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

Conditions
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Healthy Male Adults

Intervention / Treatment
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* Drug: ASC-01
* Drug: Aripiprazole and sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC-01 in period 1, Aripiprazole and sertraline in period 2<br>At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. | Drug: ASC-01<br>* Aripiprazole 3 mg/sertraline 100 mg combination drug<br>Drug: Aripiprazole and sertraline<br>* Aripiprazole 3 mg and sertraline 100 mg<br>|
| Experimental: Aripiprazole and sertraline in period 1, ASC-01 in period 2<br>At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. | Drug: ASC-01<br>* Aripiprazole 3 mg/sertraline 100 mg combination drug<br>Drug: Aripiprazole and sertraline<br>* Aripiprazole 3 mg and sertraline 100 mg<br>|
| Experimental: Fasting in period 1, After breakfast in period 2<br>At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. | Drug: ASC-01<br>* Aripiprazole 3 mg/sertraline 100 mg combination drug<br>Drug: Aripiprazole and sertraline<br>* Aripiprazole 3 mg and sertraline 100 mg<br>|
| Experimental: After breakfast in period 1, Fasting in period 2<br>At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. | Drug: ASC-01<br>* Aripiprazole 3 mg/sertraline 100 mg combination drug<br>Drug: Aripiprazole and sertraline<br>* Aripiprazole 3 mg and sertraline 100 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1 |  | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing | 
| Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1 |  | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing | 
| Cmax of Aripiprazole and Sertraline in Cohort 2 |  | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing | 
| AUC168h of Aripiprazole and Sertraline in Cohort 2 |  | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing |