Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects
| Autor: | Panjaitan Ly, Theresia Sinandang, Felicia, Azmi F, Windy Lusthom, Budi Prasaja, Yahdiana Harahap, Lia Yumi Yusvita |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty Chemistry Pharmaceutical Urology Cmax Pharmacology Bioequivalence 030226 pharmacology & pharmacy Bioequivalence study 03 medical and health sciences 0302 clinical medicine Pharmacokinetics medicine Humans Pharmacology (medical) Rosuvastatin Rosuvastatin Calcium Cross-Over Studies Crossover study Confidence interval Bioavailability Therapeutic Equivalency Area Under Curve Female Hydroxymethylglutaryl-CoA Reductase Inhibitors Tablets medicine.drug |
| Zdroj: | Int. Journal of Clinical Pharmacology and Therapeutics. 54:212-216 |
| ISSN: | 0946-1965 |
| DOI: | 10.5414/cp202345 |
| Popis: | Aim To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. Methods 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIon-Spray mode. Pharmacokinetic parameters AUC(0-t), AUC(0-∞), and Cmax were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated nonparametrically. Results The estimated point and 90% confidence intervals (CI) for AUC(0-t), AUC(0-∞), and C(max) for rosuvastatin were 95.21% (87.56 - 103.53%), 95.76% (88.01 - 104.18%), and 99.33% (89.37 - 110.41%), respectively. Conclusion These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|