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

Hyperplasia Prostatic Clinical Trial

— BET04cap  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01338623
• Other study ID #: P03/11
• Status: Recruiting
• Phase: Phase 4
• First received: April 18, 2011
• Last updated: May 2, 2011
• Start date: April 2011
• Est. completion date: May 2011

Study information

• Verified date: April 2011
• Source: Biocinese
• Contact: Josélia Manfio, Dr
• Phone: +55 45 21031900
• Email: biocinese[@]biocinese.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperplasia
• Hyperplasia Prostatic

Intervention

Drug:
• Tansulosine
capsule 0,4 mg

Locations

Country	Name	City	State
Brazil	Biocinese	Toledo	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Biocinese

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence interval	Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.	3 months	No

External Links

•   Biocinese