RESUMEN
Telmisartan is highly variable drug indicated for treatment of hypertension. This study aimed to compare the bioavailability of two 80 mg telmisartan tablets in healthy Indonesian subjects. A randomized, open-label, single-dose, three-sequence, three-way, reference-formulation-replicated crossover study was conducted under fasting period with two-week washout period. In this study, 31 Indonesian subjects were enrolled and 28 subjects were completed the study. Serial blood samples were collected up to 72 h following drug administration. Plasma concentrations of telmisartan were determined using high-performance liquid chromatography method with fluorescence detector. The pharmacokinetic parameters of AUC0- t , AUC0-∞, and C max were assessed for bioequivalence. Bioequivalence acceptance was based on predefined criteria of 90% confidence interval (CI) of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max. The 90% CI for AUC0- t , AUC0-∞, and C max was 96.11-107.25%, 93.06-104.36%, and 94.23-127.01%, respectively. These results indicated that the two formulations of telmisartan were bioequivalent.
Asunto(s)
Telmisartán , Administración Oral , Área Bajo la Curva , Disponibilidad Biológica , Estudios Cruzados , Humanos , Indonesia , Comprimidos , Equivalencia TerapéuticaRESUMEN
AIM: To compare the bioequivalence of two 10-mg memantine tablet formulations. MATERIALS AND METHODS: 19 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 5-week washout period was applied. Blood samples were collected up to 72 hours following drug administrations. Plasma memantine concentrations were determined by LC-MS/MS. The pharmacokinetic parameters AUC0-72h and Cmax were calculated and used for bioequivalence evaluation after log-transformation. RESULTS: The point estimates and 90% confidence intervals for AUC0-72h and CCmax for memantine were 100.72% (97.43 - 104.13%) and 101.46% (97.15 - 105.96%), respectively. CONCLUSION: These results indicated that the two formulations of memantine were bioequivalent; therefore, they may be prescribed interchangeably.