GSK-ARI109882

Study Sponsor: GSK

Study Title

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

Medicine or Vaccine (generic name)

dutasteride

Sponsor Identification Number

ARI109882

Trial Registry Identification Number(#'s)

NCT00537654

Medical Condition

Prostatic Hyperplasia

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=ARI109882

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT00537654

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

March 2014