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A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. (ARI114694)
|ClinicalTrials.gov Identifier: NCT01254071|
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : June 12, 2017
Information provided by (Responsible Party):
No Study Results Posted on ClinicalTrials.gov for this Study
|Recruitment Status :||Completed|
|Primary Completion Date :||December 21, 2010|
|Study Completion Date :||December 21, 2010|
Flomax (Tamsulosin hydrochloride) Product Information for the USA, 2009
GlaxoSmithKline Document Number ZM2007/00022/00. ARI109882. An Open-Label, Randomized, Single Dose, Three-Period 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, August 2007
GlaxoSmithKline studyARI40005: A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5mg) and Tamsulosin (0.4mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia; [GlaxoSmithKline Document Number HM2002/00171/01].
Harnal capsule (Tamsulosin hydrochloride), 0.4mg Product Information for Australia, 2009b.
Harnal D (Tamsulosin hydrochloride), extended release tablet, 0.2mg Product Information for Hong Kong, 2009a.
Matsushima H, Kamimura H, Soeishi Y, Watanabe T, Higuchi S, Tsunoo M. Pharmacokinetics and plasma protein binding of tamsulosin hydrochloride in rats, dogs, and humans. Drug Metab Dispos. 1998 Mar;26(3):240-5.
McConnell JD. The long term effects of medical therapy on the progression of BPH: Results from the MTOPS Trial (abstract 1042). J. Urology 167 (4):265, 2002.