生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Study of Metformin HCl XR Caplet Formulations in Healthy Indonesian Volunteers

Yahdiana Harahap, Santi Purnasari, Hayun, Krisnasari Dianpratami, Mahi Wulandari, Rina Rahmawati, Fadlina Chany and Radite Nusa Senjaya

Aim: Determination of the bioequivalence of two metformin HCl (750 mg) caplet formulations (Glucophage XR® from Bristol-Myres Squibb Company, Indonesia as a reference formulation and Glumin XR® from Ferron Par Pharmaceutical, Indonesia as a test formulation). Material and method: The study was conducted according to an open label, randomized, Two-period crossover design with a 1 week washout period. Twelve volunteers participated and all completed the study successfully. Blood samples were obtained prior to dosing and at 1.0; 1.5; 2.0; 2.5; 3.0; 3.5; 4.0; 6.0; 8.0; 10.0; 14.0; 18.0; 24.0 and 30.0 hours after drug administration. Plasma will be separated by centrifuge and stored frozen at -20 degree Celcius. Plasma concentration of metformin HCl was monitored using high performance liquid chromatography (HPLC) with photo diode array (PDA) detection over a period of 30 hours after administration. The pharmacokinetics parameter AUC 0-30 h, AUC 0-∞ and Cmax were tested for bioequivalence after log transformation of data and ratios of Tmax were evaluated non parametrically. Result: The point estimates and 90% confidence interval for AUC 0-30 h, AUC 0-∞ and Cmax were 101.88 % (94.78-109.50%), 101.50% (93.77- 109.87%) and 105.93 % (97.00-115.98%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and The US Food and Administration Guidelines. Conclusion: These results indicate that two medications of metformin HCl are bioequivalent, thus, may be prescribed interchangeably.