Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-label, Single-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a Tablet Containing 75 mg of Clopidogrel and 100 mg of Aspirin and The Simultaneous Administration of The Separate Formulations of The Two Drugs in Healthy Male Volunteers|
- Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid [ Time Frame: upto 24 hours after dosing ] [ Designated as safety issue: No ]Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, PO, 2 tablet once daily for Period I & II Day 1 (crossover manner)
Active Comparator: Plavix/Astrix
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin), 2 tablets once daily for Period I & II Day 1 (crossover manner)
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou Medical Center on the day before dosing, and they will overnight-fasted from 10 p.m. of Day -1.
Subjects will be dosed study drug (a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, or the simultaneous administration of the separate formulations of the two drugs) orally with 240 mL of water around 8 a.m. of Day 1. Subjects will be performed scheduled pharmacokinetic sampling upto 24 hours.
After 2 weeks of washout period, Subjects will be dosed study drug by crossover manner, and will be performed scheduled pharmacokinetic sampling upto 24 hours.
Study participation will be ended on post-study visit (Day 25).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388660
|Contact: Doo-Yeoun Cho, MDemail@example.com|
|Korea, Republic of|
|Ajou University School of Medicine||Recruiting|
|Suwon, Gyeonggi, Korea, Republic of, 433-721|
|Contact: Doo-Yeoun Cho, MD +82-31-219-4271 firstname.lastname@example.org|
|Sub-Investigator: Young-Sang Kim, MD|
|Principal Investigator:||Doo-Yeoun Cho, MD||Ajou University School of Medicine|