NCT02010632

Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products

Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers

Detailed description

Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).

Conditions

• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Generic clopidogrel product Apolets®	* Clopidogrel 75 mg once daily for 7 days * Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
DRUG	Original clopidogrel product Plavix®	* Clopidogrel 75 mg once daily for 7 days * Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2013-12-13
• Last updated: 2015-05-04
• Results posted: 2015-05-04

Locations

1 site across 1 country: Thailand