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NCT00865605 · ClinicalTrials.gov registry record · Phase 1

Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects

A Phase 1 study, sponsored by Actavis.

Completed
Registry status
Phase 1
Development phase
71
Enrollment target

NCT00865605 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 71 participants.

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The verdict

NCT00865605, a Phase 1 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 1
Development phase
71 participants
Enrollment target

Study Summary

The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).

Interventions

  • DRUG Ultravate® 0.05% ointment, single exposure
  • DRUG Halobetasol Propionate 0.05% Ointment, single exposure

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2003-12
Est. Completion 2004-07
Phase Phase 1

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT00865605

The ClinicalTrials.gov registry entry for NCT00865605 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ultravate® 0.05% ointment, single exposure is the first listed.

NCT00865605 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00865605 about?

NCT00865605 is a clinical study titled "Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects". The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).

What is the current status of trial NCT00865605?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2003-12. Estimated completion is 2004-07.

What interventions are being tested in trial NCT00865605?

The interventions under investigation include: Ultravate® 0.05% ointment, single exposure (DRUG), Halobetasol Propionate 0.05% Ointment, single exposure (DRUG).

Who is sponsoring clinical trial NCT00865605?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.