Bioequivalence Study of Torasemide Tablets in Healthy Chinese Volunteers
- Author:
Xiao-Wen ZHOU
1
Author Information
- Publication Type:Journal Article
- Keywords: Bioequivalence; HPLC-MS; Torasemide
- From: Chinese Pharmaceutical Journal 2017;52(16):1442-1446
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To evaluate the bioequivalence of tested and reference torasemide tablets in healthy male volunteers. METHODS: A single oral dose of the two formulations was given to 24 healthy male volunteers according to a randomized crossover design. Plasma drug concentrations were determined by HPLC-MS. RESULTS: The pharmacokinetic parameters of torasemide of the two preparations were as follows: ρmax (1 408.29±337.27) and (1 487.86±360.24) ng·mL-1, tmax (0.90±0.42) and (1.03±0.50) h, t1/2(4.43±0.57) and (4.43±0.60) h, MRT (3.90±0.60) and (4.01±0.72) h, AUC0-24 h(3 886.86±865.99) and (3 906.06±761.72) ng·h·mL-1, AUC0-∞ (3 936.57±903.93) and (3 956.96±789.98) ng·h·mL-1, respectively. The relative bioavailability of tested torasemide tablets were (99.8±11.7)% and (99.7±12.0)% when calculated by AUC0-24 h and AUC0-∞, respectively. CONCLUSION: The two formulations of torasemide are bioequivalent in healthy Chinese volunteers.
