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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

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ClinicalTrials.gov Identifier: NCT03342963
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief 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).


Condition or disease Intervention/treatment Phase
Healthy Male Adults Drug: ASC-01 Drug: Aripiprazole and sertraline Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASC-01 in period 1, Aripiprazole and sertraline in period 2

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
Aripiprazole 3 mg/sertraline 100 mg combination drug

Drug: Aripiprazole and sertraline
Aripiprazole 3 mg and sertraline 100 mg

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

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
Aripiprazole 3 mg/sertraline 100 mg combination drug

Drug: Aripiprazole and sertraline
Aripiprazole 3 mg and sertraline 100 mg

Experimental: Fasting in period 1, After breakfast in period 2

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
Aripiprazole 3 mg/sertraline 100 mg combination drug

Drug: Aripiprazole and sertraline
Aripiprazole 3 mg and sertraline 100 mg

Experimental: After breakfast in period 1, Fasting in period 2

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
Aripiprazole 3 mg/sertraline 100 mg combination drug

Drug: Aripiprazole and sertraline
Aripiprazole 3 mg and sertraline 100 mg




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of aripiprazole (Cohort 1) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168 h after dosing ]
  2. Area under the plasma concentration versus time curve 168h(AUC168h) of aripiprazole (Cohort 1) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168 h after dosing ]
  3. Cmax of aripiprazole and sertraline (Cohort 2) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168 h after dosing ]
  4. AUC168h of aripiprazole and sertraline (Cohort 2) [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168 h after dosing ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342963


Locations
Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03342963     History of Changes
Other Study ID Numbers: 031-102-00214
JapicCTI-173774 ( Other Identifier: Japic )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aripiprazole
Sertraline
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents