|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00609596 |
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.
Condition | Intervention | Phase |
Benign Prostatic Hyperplasia |
Drug: GI198745 |
Phase I |
Drug Information available for: | Dutasteride Tamsulosin Tamsulosin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open Label, Randomized, Repeat Dose, 3 Period Cross Over Study to Determine the Bioequivalence of 3 Different Formulations of Tamsulosin at Steady State in Healthy Male Volunteers |
Estimated Enrollment: | 24 |
Study Start Date: | February 2008 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of >14 drinks/week. One drink is equivalent to: 12 g alcohol = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ARI111402 |
First Received: | January 25, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00609596 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|