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

Abstract

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 Seven subjects were withdrawn during the periods.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 AUC_0−∞ of reference tablet and test tablet was 3290 ± 2270 and 3080 ± 2010 ng h/mL, respectively; the mean C_max was 674 ± 366 and 612 ± 252 ng/mL, respectively; the mean T_max was 0.92 ± 0.44 and 0.99 ± 0.46 h, respectively. The results of HCTZ were as follows: the mean AUC_0−∞ of reference tablet and test tablet was 525 ± 94.3 and 536 ± 96.8 ng h/mL, respectively; the mean C_max was 90.8 ± 25.4 and 86.2 ± 21.4 ng/mL, respectively; the mean T_max 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 AUC_0−t and C_max 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.