Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00537654 · ClinicalTrials.gov registry record · Phase 1
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT00537654 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 81 participants.
The verdict
NCT00537654, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram \[mg\]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
Interventions
- DRUG Treatment sequence A
- DRUG Treatment sequence B
- DRUG Treatment sequence C
- DRUG Treatment sequence D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2007-10-18 |
| Est. Completion | 2008-02-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00537654
The ClinicalTrials.gov registry entry for NCT00537654 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Treatment sequence A is the first listed.
NCT00537654 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00537654 about?
NCT00537654 is a clinical study titled "A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State". This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram \[mg\]/0.4 mg) relative...
What is the current status of trial NCT00537654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2007-10-18. Estimated completion is 2008-02-22.
What interventions are being tested in trial NCT00537654?
The interventions under investigation include: Treatment sequence A (DRUG), Treatment sequence B (DRUG), Treatment sequence C (DRUG), Treatment sequence D (DRUG).
Who is sponsoring clinical trial NCT00537654?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.