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

NCT00865605 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2010-08-17

No results posted yet for this 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.).

Conditions

  • Healthy

Interventions

DRUG

Halobetasol Propionate 0.05% Ointment, single exposure

A: Other Subjects received Alpharma/Purepac USHP formulated products

DRUG

Ultravate® 0.05% ointment, single exposure

Subjects received Bristol-Myers Squibb Company formulated products

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Paul A. Lehman,, M.Sc. · DermTech International

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2004-07-31
Completion
2004-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865605 on ClinicalTrials.gov