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Bioequivalence - Duodart Against Avodart & Omnic

NCT01657851 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-06-20

No results posted yet for this study

Summary

Open-label, randomized, single dose, two-treatment, two-way crossover study

Conditions

  • Prostatic Hyperplasia

Interventions

DRUG

dutasteride/tamsulosin

Duodart® 0.5 mg / 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

DRUG

dutasteride

Avodart® 0.5 mg together with Omnic® 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

DRUG

tamsulosin

Omnic® 0.4 mg together with Avodart® 0.5 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-08-23
Primary Completion
2012-12-05
Completion
2012-12-05

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

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 NCT01657851 on ClinicalTrials.gov