Bioequivalence study comparing a fixed-dose combination of clopidogrel and enteric aspirin versus the simultaneous administration of separate formulations in healthy Korean male subjects
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001205
- Lead Sponsor
- Sanofi-Aventis Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 150
Korean male subjects, between 19 and 55 years of age, inclusive.
Body weight between 50.0 and 100.0 kg, inclusive, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
Certified as healthy by a comprehensive clinical assessment.
Having given written informed consent prior to undertaking any study-related procedure.
Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV 1 and anti-HIV2 Ab), syphilis RPR antibodies.
Positive result on urine drug screen (amphetamines/methamphetamines,barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
Positive alcohol breath test.
Any contraindication to clopidogrel or ASA.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of PK parameter - area under the curve over the time (AUC) from time zero to the time of last quantifiable concentration (AUClast) for clopidogrel and ASA;Assessment of PK parameter - maximum concentration (Cmax) for clopidogrel and ASA
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter - terminal half-life (t1/2z) for clopidogrel and ASA;Number of subjects with adverse events;Assessment of PK parameter - time to reach Cmax (tmax) for clopidogrel and ASA;Assessment of PK parameter - AUC for clopidogrel and ASA