Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State (BET04cap)
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State|
- Bioequivalence interval [ Time Frame: 3 months ] [ Designated as safety issue: No ]Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||May 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
capsule 0,4 mg
Other Name: Omics
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338623
|Toledo, Paraná, Brazil, 85903-590|
|Principal Investigator:||Josélia Manfio, Dr||Biocinese|