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

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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
Sponsor:
Information provided by:
Biocinese

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperplasia Prostatic Drug: Tansulosine Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Tansulosine Drug: Tansulosine
capsule 0,4 mg
Other Name: Omics



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Dr Josélia Larger Manfio, Biocinese
ClinicalTrials.gov Identifier: NCT01338623     History of Changes
Other Study ID Numbers: P03/11
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: April 2011

Keywords provided by Biocinese:
bioequivalence
tansulosine

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes