Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State
Status:
Unknown status
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the bioavailability (rate and extent of absorption)
of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover
study with a seven-days washout interval was conduced in 32 healthy male volunteers. The
plasma samples were obtained up to 72 hours after drug administration. A sensitive and
specific LC-MS/MS method was developed and validated for the determination of tansulosine in
human plasma. Bioequivalence between the products was determined by calculating 90%
confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.