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NCT01577693 · ClinicalTrials.gov registry record · Phase 1

Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
35
Enrollment target

NCT01577693: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT01577693 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01577693, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
35 participants
Enrollment target

Study Summary

The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects.

Primary Outcome

To assess the dutasteride relative bioavailability of the of 0.5 mg novel formulation compared with the currently marketed 0.5 mg soft gelatin capsule.

Interventions

  • DRUG dutasteride

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2011-05-12
Est. Completion 2011-08-31
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT01577693 record still lists

NCT01577693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 1 intervention - of which dutasteride is the first listed.

NCT01577693 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01577693 about?

NCT01577693 is a clinical study titled "Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects". The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects.

What is the current status of trial NCT01577693?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2011-05-12. Estimated completion is 2011-08-31.

What interventions are being tested in trial NCT01577693?

The interventions under investigation include: dutasteride (DRUG).

Who is sponsoring clinical trial NCT01577693?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01577693's enrollment target sits among peer trials

35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01577693, the US trial registry maintained by the National Library of Medicine. NCT01577693 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.