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

Healthy Male Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342963
• Other study ID #: 031-102-00214
• Secondary ID: JapicCTI-173774
• Status: Completed
• Phase: Phase 1
• Start date: November 21, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: April 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male Adults

Intervention

Drug:
• ASC-01
Aripiprazole 3 mg/sertraline 100 mg combination drug
• Aripiprazole and sertraline
Aripiprazole 3 mg and sertraline 100 mg

Locations

Country	Name	City	State
Japan	Clinic of Kyusyu Region	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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