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Sponsored by: |
Perrigo Company |
---|---|
Information provided by: | Perrigo Company |
ClinicalTrials.gov Identifier: | NCT00803218 |
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.
Condition | Intervention |
---|---|
Healthy |
Drug: Fluticasone Propionate 0.005% Ointment-Reference Product Drug: Fluticasone Propionate 0.005% Ointment-Test product |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments |
Enrollment: | 56 |
Study Start Date: | November 2002 |
Study Completion Date: | November 2002 |
Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Cohort Group 1
Subjects number 1 to 26
|
Drug: Fluticasone Propionate 0.005% Ointment-Reference Product
Small amount applied and evaluated over the course of one day
Drug: Fluticasone Propionate 0.005% Ointment-Test product
Small amount applied and evaluated over the course of one day
|
Cohort Group 2
Subjects number 27 to 56
|
Drug: Fluticasone Propionate 0.005% Ointment-Reference Product
Small amount applied and evaluated over the course of one day
Drug: Fluticasone Propionate 0.005% Ointment-Test product
Small amount applied and evaluated over the course of one day
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Healthy Community Volunteers
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Perrigo ( Linda Gans ) |
Study ID Numbers: | 10216916 |
Study First Received: | December 2, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00803218 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Fluticasone Propionate |
Anti-Inflammatory Agents Anti-Asthmatic Agents Fluticasone Anti-Allergic Agents |
Peripheral Nervous System Agents Healthy Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Anti-Asthmatic Agents |
Fluticasone Anti-Allergic Agents Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pharmacologic Actions |