NCT00865605

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

A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Pivotal Bioequivalence Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.).

Detailed description

Study Type: Interventional Study Design: A single blind, single-exposure study on healthy adult male and female subjects. Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Pivotal Bioequivalence Study Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Vasoconstrictor Response

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-12-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States