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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00537654 |
AVODART 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 the drugs work the same in the body when giving AVODART and FLOMAX at the same time compared to when they are given in a combination capsule in a fed and fasted state. This study will be in healthy adult males.
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia |
Drug: GI198745 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | See Detailed Description |
Enrollment: | 81 |
Study Start Date: | October 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
United States, Indiana | |
GSK Investigational Site | |
Evansville, Indiana, United States, 47714 | |
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78752 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ARI109882 |
Study First Received: | September 28, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00537654 |
Health Authority: | United States: Food and Drug Administration |
benign prostatic hyperplasia, AVODART, FLOMAX |
Dutasteride Hyperplasia Prostatic Diseases |
Prostatic Hyperplasia Tamsulosin Genital Diseases, Male |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |