A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
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ClinicalTrials.gov Identifier: NCT02088697 |
Recruitment Status :
Completed
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Drug: Placebo Drug: ASC-01 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: ASC-01 placebo
A single oral dose of ASC-01 Placebo (sertraline 100 mg)
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Drug: Placebo |
Active Comparator: Sertraline tablet
A single oral dose of sertraline tablets (sertraline 100 mg)
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Drug: ASC-01 |
- Bioequivalence of ASC-01 placebo and sertraline tablet by assessment of Cmax and Area Under Curve (AUC) [ Time Frame: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose ]
- AUC(0-inf), MRT(0-inf), Tmax, λz, AUC_%Extrap, T half, CL/F, CL/F/BW, Vz/F and Vz/F/BW of sertraline [ Time Frame: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose ]

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male volunteers aged 20 to 40 years.
- Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.
Exclusion Criteria:
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

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): NCT02088697
Japan | |
Osaka Pharmacology Clinical research Hospital | |
Osaka, Japan |
Responsible Party: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02088697 History of Changes |
Other Study ID Numbers: |
031-13-003 |
First Posted: | March 17, 2014 Key Record Dates |
Last Update Posted: | March 17, 2014 |
Last Verified: | March 2014 |
Additional relevant MeSH terms:
Sertraline Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |