Bioequivalence of Telmi plus V tablet 80/12.5 mg to Micardis plus tablet 80/12.5 mg (telmisartan/hydrochlorothiazide 80/12.5 mg)

摘要

The aim of this study is to assess the quality of Telmi plus V? tablet (test formulation) by comparing its pharmacokinetic parameters with Micardis plus? tablet (reference formulation) in forty healthy Korean male volunteers. Seven subjects were withdrawn during the periods. This study was performed under fasted condition with a randomized, single-dose, 2-period crossover design. The dissolution studies of both formulations were conducted using USP apparatus 2 at 75 rpm with 1000 mL of phosphate buffer solution (pH 7.5) at 37 ± 0.5 °C. Forty healthy Korean male volunteers were enrolled in this study with 19–34 years (24.7 ± 3.9), height 164–184 cm (174.9 ± 5.3) and weight 52–85 kg (71.2 ± 9.0). The results of telmisartan were as follows: the mean AUC0?∞ of reference tablet and test tablet was 3290 ± 2270 and 3080 ± 2010 ng h/mL, respectively; the mean Cmax was 674 ± 366 and 612 ± 252 ng/mL, respectively; the mean Tmax was 0.92 ± 0.44 and 0.99 ± 0.46 h, respectively. The results of HCTZ were as follows: the mean AUC0?∞ of reference tablet and test tablet was 525 ± 94.3 and 536 ± 96.8 ng h/mL, respectively; the mean Cmax was 90.8 ± 25.4 and 86.2 ± 21.4 ng/mL, respectively; the mean Tmax was 1.58 ± 0.60 and 1.78 ± 0.66 h, respectively. The 90 % confidence intervals for geometric mean ratios of test to reference formulation of AUC0?t and Cmax were 0.9132–1.0441 and 0.8579–1.1048 for telmisartan, and 0.9737–1.0713 and 0.8801–1.0326 for HCTZ, respectively. The results of this study in healthy Korean male volunteers showed that the test and reference formulations of 80/12.5 mg telmisartan/hydrochlorothiazide met the MFDA regulatory criteria for bioequivalence. Both formulations were well tolerated, with no serious adverse events reported.