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NCT02509104 · ClinicalTrials.gov registry record · Phase 1
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT02509104 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 56 participants.
The verdict
NCT02509104, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram \[mg\]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects in fed and fasted states. This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride 0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period. Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods. The two treatment periods will be separated by a minimum washout period of 28 days. The total duration in the study for each subject will be approximately 2.5 months from screening to the final follow-up visit.
Interventions
- DRUG FDC capsule of dutasteride and tamsulosin
- DRUG Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-07-30 |
| Est. Completion | 2015-10-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02509104
The ClinicalTrials.gov registry entry for NCT02509104 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 2 interventions - of which FDC capsule of dutasteride and tamsulosin is the first listed.
NCT02509104 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02509104 about?
NCT02509104 is a clinical study titled "Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects". The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram \[mg\]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects ...
What is the current status of trial NCT02509104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2015-07-30. Estimated completion is 2015-10-10.
What interventions are being tested in trial NCT02509104?
The interventions under investigation include: FDC capsule of dutasteride and tamsulosin (DRUG), Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet (DRUG).
Who is sponsoring clinical trial NCT02509104?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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