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Completed

NCT Number: NCT03342963

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

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).

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Key information

Conditions

Healthy Male Adults

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinic of Kyusyu Region

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC-01

Drug

Aripiprazole 3 mg/sertraline 100 mg combination drug

Aripiprazole and sertraline

Drug

Aripiprazole 3 mg and sertraline 100 mg

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1

    Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

  2. Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1

    Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

  3. Cmax of Aripiprazole and Sertraline in Cohort 2

    Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

  4. AUC168h of Aripiprazole and Sertraline in Cohort 2

    Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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