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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Male Adults

Treatments: Drug: Aripiprazole and sertraline; Drug: ASC-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT03342963

031-102-00214

JapicCTI-173774 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 74 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

74 participants in 4 patient groups

ASC-01 in period 1, Aripiprazole and sertraline in period 2

Experimental group

Description:

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.

Treatment:

Drug: ASC-01

Drug: Aripiprazole and sertraline

Aripiprazole and sertraline in period 1, ASC-01 in period 2

Experimental group

Description:

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.

Treatment:

Drug: ASC-01

Drug: Aripiprazole and sertraline

Fasting in period 1, After breakfast in period 2

Experimental group

Description:

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.

Treatment:

Drug: ASC-01

Drug: Aripiprazole and sertraline

After breakfast in period 1, Fasting in period 2

Experimental group

Description:

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.

Treatment:

Drug: ASC-01

Drug: Aripiprazole and sertraline