Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
This study has been completed.
Sponsor:
Perrigo Company
Information provided by:
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00803218
First received: December 2, 2008
Last updated: March 15, 2012
Last verified: March 2012
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Purpose
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: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments |
Resource links provided by NLM:
Further study details as provided by Perrigo Company:
Primary Outcome Measures:
- Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter [ Time Frame: Over the course of one day ] [ Designated as safety issue: No ]
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy Community Volunteers
Criteria
Inclusion Criteria:
- Non-tobacco using female subjects, 18 to 50 years of age
- Demonstrated blanching response to Reference Drug
- Weight within +/- 20% from normal for height and weight for body frame
- Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
- Signed and dated informed consent form which meets all criteria of current FDA regulations
Exclusion Criteria:
- History of allergy to systemic or topical corticosteroids
- Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
- Presence of medical condition requiring regular treatment with prescription drugs
- Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
- Use of any tobacco products in the 30 days prior to study dosing
- Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
- Receipt of any drugs as part of a research study within 30 days prior to study dosing
- Pregnant or lactating
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Linda Gans, Perrigo |
| ClinicalTrials.gov Identifier: | NCT00803218 History of Changes |
| Other Study ID Numbers: | 10216916 |
| Study First Received: | December 2, 2008 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Perrigo Company:
|
Bioequivalence Fluticasone Propionate |
Additional relevant MeSH terms:
|
Fluticasone Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013