Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biocinese

Criteria

Inclusion Criteria:

• They were within 10% of their ideal body weight.

• Biochemical test and physical examination were carried out.

• No concomitant medications were allowed.

• Volunteers did not drink caffeine-containing drinks 48-hours before the study.

• The volunteers gave written informed consent to participate in the study.

Exclusion Criteria:

• Chronic disease

• Smokers