Bioequivalence study of two formulations of simvastatin tablets in healthy Thai volunteers
| Autor: | Ornrat Lohitnavy, Sanglar Polnok, Kasinee Chaijittiprasert, Manupat Lohitnavy, Prawit Taytiwat |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Simvastatin Spectrometry Mass Electrospray Ionization Adolescent Metabolite Chemistry Pharmaceutical Cmax Bioequivalence Pharmacology Dosage form chemistry.chemical_compound Pharmacokinetics Drug Discovery medicine Humans Chromatography High Pressure Liquid Cross-Over Studies business.industry Anticholesteremic Agents Middle Aged Thailand Crossover study Bioavailability chemistry Therapeutic Equivalency Area Under Curve business medicine.drug Half-Life Tablets |
| Zdroj: | Scopus-Elsevier |
| ISSN: | 0004-4172 |
| Popis: | The bioequivalence of two formulations of 10 mg tablets of simvastatin (CAS 79902-63-9), Vascor® as test and a commercially available preparation as reference, in 18 healthy Thai male volunteers was assessed. In a randomized, single dose, two-period, crossover study design with a 1 -week wash-out period, each subject received 4 tablets of 10-mg simvastatin tablets. Plasma samples were collected over a 24-h period after administration. Subsequently, plasma concentrations of simvastatin and its hydroxy acid metabolite were analyzed by using LC/MS/MS. Pharmacokinetic parameters were determined by using non-compart-mental analysis. The results showed that 90% confidence intervals of the peak concentration (Cmax) and the area under the concentration-time curve (AUC) of simvastatin and its hydroxy acid metabolite of reference and test were within 80 %–125 %. Consequently the bioequivalence of these two preparations can be concluded. |
| Databáze: | OpenAIRE |
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