A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.

Phase 1

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: GI198745

• Registration Number: NCT00609596
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-07
• Study Start: 2008-02-26
• Primary Completion: 2008-04-23
• Study Completion: 2008-04-23
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	GI198745	-

Primary Outcome Measures

Name	Time	Method
PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72

Secondary Outcome Measures

Name	Time	Method
Clinical safety labs	at check in
measurement of orthostatic hypotension	at 6 hours post dose on days 1 and 7
adverse event reporting
C(tau) (pre-dose concentrations determined immediately before a dose at steady state), t1/2, tmax, lambda, Cmin and fluctuation [(Cmax - Cmin)/(AUC(0-24)/24)] of tamsulosin, as data permit.
Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, adverse events and clinical laboratory safety tests.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Buffalo, New York, United States