An open-label, randomized, 2-treatment, 3-period, 3-sequence crossover bioequivalence study comparing a tablet containing clopidogrel and enteric aspirin versus the simultaneous administration of separate formulations of these two drugs in healthy Korean male subjects

Sanofi-Aventis Korea0 个研究点目标入组 150 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•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.

发起方

Sanofi-Aventis Korea