| DOI: https://doi.org/10.14456/mujps.2015.4 | Pharm Sci Asia 2015; 42(1), 8-13 |
Bioequivalence study of torsemide 10 mg tablets in healthy Thai volunteersP. Teerawonganan1, E. Yoosakul1, P. Ratnatilaka Na Bhuket1, B. Chuasuwan1, I. Techatanawat1*, P. Narakorn1, A. Rojanawiwat2, A. Eksaengsri1
1 The Government Pharmaceutical Organization, 75/1 Rama VI Road, Ratchathewi, Bangkok 10400 Thailand
2 Clinical Research Center, Department of Medical Sciences, Ministry of Public Health, Thiwanon Rd., Muang, Nonthaburi, 11000 Thailand
Torsemide is a member of high-ceiling loop diuretics which inhibits the Na+/K+/2Cl- symporter in the thick ascending loop of Henle resulting in substantial diuresis and saluresis. Torsemide is indicated for management of edema associated with heart failure and hepatic or renal disease and can be used alone or combined with other antihypertensive drugs in treatment of hypertension. Because there is only one brand of torsemide in Thailand, the Government Pharmaceutical Organization (GPO) has developed a generic product with lower price which would give opportunity for patients to access this medicine. A randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of generic torsemide 10 mg tablets of GPO, Thailand, and the reference product, Unat®, of Roche Farma SA, Spain, in healthy human male and female adult subjects, under fasting conditions was conducted. Washout period was 7 days between treatments. Blood samples were collected at predefined time points up to 24 hours. Plasma concentrations of torsemide were analyzed using liquid chromatography tandem mass spectrometry. Non-compartmental model was used for pharmacokinetic analysis. The 90% CI for the ratios of mean AUC0-tlast, AUC0-∞ and Cmax for the test/reference were 96.5 (93.86-99.29), 96.6 (93.97-99.37) and 91.2 (85.64-97.06), respectively. These values were within the acceptable range of 80.00-125.00. No clinically significant or serious ADRs were observed during the study. Therefore, this study confirmed that Torsemide GPO 10 mg tablets can be used interchangeably to Unat® 10 mg tablets.
Keyword:
Torsemide, Pharmacokinetics, Bioequivalence, Liquid chromatography tandem mass spectrometry
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