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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperplasia Prostatic
• Intervention / Treatment: Drug: Tansulosine

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
• Enrollment (Anticipated): 32
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Josélia Manfio, Dr; Phone Number: +55 45 21031900; Email: biocinese@biocinese.com.br
• Study Contact Backup: Name: Josélia Manfio, Dr; Phone Number: +55 45 2103-1900; Email: biocinese@biocinese.com.br

Study Locations

• Brazil
  • Paraná
    • Toledo, Paraná, Brazil, 85903-590
      • Recruiting
      • Biocinese
      • Contact: Biocinese; Phone Number: +55 45 2103-1900; Email: biocinese@biocinese.com.br
      • Principal Investigator: Josélia Manfio, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tansulosine	Drug: Tansulosine; capsule 0,4 mg; Other Names: Omics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biocinese
• Investigators: Principal Investigator: Josélia Manfio, Dr, Biocinese

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2011
• Last Update Submitted That Met QC Criteria: May 2, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: bioequivalence; tansulosine
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: P03/11