Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State (BET04cap)

Biocinese

Status and phase: Unknown; Phase 4

Conditions: Hyperplasia Prostatic

Treatments: Drug: Tansulosine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338623

P03/11

Details and patient eligibility

About

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.

Full description

The study protocol was approved by Local Ethics Committee (UNICAMP - Campinas, Brazil). The study was performed with 32 healthy male volunteers. They were within 10% of their ideal body weight. Biochemical test and physical examination were carried out. Their medical history was also obtained. . Volunteers did not drink caffeine-containing drinks 48-hours before the study. The volunteers gave written informed consent to participate in study.

The study was designed as two-single-dose, randomized, open-label, balanced, crossover study, with two periods separated by 7-days washout. In both periods after a standard breakfast volunteers were given a single dose of their formulation (reference or test) of tansulosine with 200 mL of water. Blood samples (8 ml) were collected at 0 (pre-dose) and at 01:00; 02:00; 03:00; 04:00; 04;30; 05:00; 05:20; 05:40; 06:00; 06:20; 06:40; 07:00; 07:30; 08:00; 08:30; 09:00; 10:00; 12:00; 24:00; 48:00; 72:00h. These samples were centrifuged immediately and kept frozen at -20°C until the time of analysis. Standard meals were served at 4 and 8h after administration. During hospital confinement, volunteers were always under medical supervision.

Enrollment: 32 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 1 patient group

Tansulosine

Experimental group

Treatment:

Drug: Tansulosine