Comparative pharmacodynamic effects of two clopidogrel formulations under steady-state conditions in healthy Thai volunteers
| Autor: | Wichittra Tassaneeyakul, Siriporn Tiamkao, Kutcharin Phunikhom, Sirimas Kanjanawart, Nontaya Nakkam, Wongwiwat Tassaneeyakul, Suda Vannaprasaht, Somsak Tiamkao |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Blood Platelets Male Ticlopidine Platelet Aggregation Platelet Function Tests Drug Compounding Pharmacology law.invention Young Adult P2Y12 Randomized controlled trial Asian People law Medicine Drugs Generic Humans Pharmacology (medical) cardiovascular diseases Whole blood Cross-Over Studies business.industry Drug administration Clopidogrel Thailand Crossover study Healthy Volunteers Receptors Purinergic P2Y12 Therapeutic Equivalency Pharmacodynamics Area Under Curve Purinergic P2Y Receptor Antagonists Steady state (chemistry) business Platelet Aggregation Inhibitors circulatory and respiratory physiology medicine.drug |
| Zdroj: | International journal of clinical pharmacology and therapeutics. 55(2) |
| ISSN: | 0946-1965 |
| Popis: | Objective Clopidogrel is a commonly used antiplatelet aggregation agent. Compared with the reference clopidogrel product, most commercially available generic clopidogrel products contain different crystalline forms of clopidogrel. This study was aimed to compare the pharmacodynamics of a commonly used generic clopidogrel product in Thailand with the reference clopidogrel product under steady state conditions. Methods A multiple-dose, randomized 2-way crossover study was conducted in 32 healthy male Thai volunteers. The subjects were assigned to receive 75 mg once daily of the test or the reference product for 7 days with a 2-week wash out period. Blood samples were collected on days 1, 5, 6, and 7 prior to drug administration and at 1, 2, 3, 4, 8, 12, and 24 hours after the last dose administered. The antiplatelet aggregation effects of clopidogrel were determined by using two different ex-vivo platelet aggregation tests including the whole blood impedance assay (WBA) and the VerifyNow® P2Y12 assay. Both pharmacodynamic parameters, the maximal antiplatelet effect (Emax) and the areas under the antiplatelet effect-time curve (AUEC0-24h), were calculated. Results Neither the mean values of Emax (90.70 ± 15.15 vs. 89.50 ± 10.71% inhibition) nor of AUEC0-24h (1,892.84 ± 657.22 vs. 1,853.58 ± 673.95% inhibition × h) under steady-state conditions obtained using the WBA method of these two clopidogrel products were significantly different. The results obtained using the VerifyNow® P2Y12 assay were consistent with those of the WBA assay. Conclusion This study clearly demonstrated that ex-vivo antiplatelet aggregation effect under steady-state conditions of the test product was not significantly different from the reference product. . |
| Databáze: | OpenAIRE |
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