MedTrace Logo

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

NCT01338623 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-05-03

No results posted yet for this study

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.

Conditions

  • Hyperplasia Prostatic

Interventions

DRUG

Tansulosine

capsule 0,4 mg

Sponsors & Collaborators

  • Biocinese

    lead INDUSTRY

Principal Investigators

  • Josélia Manfio, Dr · Biocinese

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338623 on ClinicalTrials.gov