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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Biocinese.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biocinese
ClinicalTrials.gov Identifier:
NCT01338623
First received: April 18, 2011
Last updated: May 2, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Hyperplasia Prostatic
Drug: Tansulosine
Phase 4

Study Type: Interventional
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

Further study details as provided by Biocinese:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 32
Study Start Date: April 2011
Estimated Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tansulosine Drug: Tansulosine
capsule 0,4 mg
Other Name: Omics

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338623

Contacts
Contact: Josélia Manfio, Dr +55 45 21031900 biocinese@biocinese.com.br
Contact: Josélia Manfio, Dr +55 45 2103-1900 biocinese@biocinese.com.br

Locations
Brazil
Biocinese Recruiting
Toledo, Paraná, Brazil, 85903-590
Contact: Biocinese    +55 45 2103-1900    biocinese@biocinese.com.br   
Principal Investigator: Josélia Manfio, Dr         
Sponsors and Collaborators
Biocinese
Investigators
Principal Investigator: Josélia Manfio, Dr Biocinese
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Josélia Larger Manfio, Biocinese
ClinicalTrials.gov Identifier: NCT01338623     History of Changes
Other Study ID Numbers: P03/11
Study First Received: April 18, 2011
Last Updated: May 2, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Biocinese:
bioequivalence
tansulosine

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014