Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State (BET04cap)
|ClinicalTrials.gov Identifier: NCT01338623|
Recruitment Status : Unknown
Verified April 2011 by Biocinese.
Recruitment status was: Recruiting
First Posted : April 19, 2011
Last Update Posted : May 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hyperplasia Prostatic||Drug: Tansulosine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||May 2011|
capsule 0,4 mg
Other Name: Omics
- Bioequivalence interval [ Time Frame: 3 months ]Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338623
|Contact: Josélia Manfio, Dr||+55 45 email@example.com|
|Contact: Josélia Manfio, Dr||+55 45 firstname.lastname@example.org|
|Toledo, Paraná, Brazil, 85903-590|
|Contact: Biocinese +55 45 2103-1900 email@example.com|
|Principal Investigator: Josélia Manfio, Dr|
|Principal Investigator:||Josélia Manfio, Dr||Biocinese|