Pivotal in vivo bioequivalence study comparing two formulations of betamethsone ointment applied to the skin in healthy male and female volunteers.
A pivotal in vivo bioequivalence study comparing two formulations of betamethsone ointment using the appropriate dose duration (ED50) calculated from the Pilot dose duration-response study, using healthy male and female volunteers who meet the responder and detector criteria.
Zenith Technology Corporation Limited
90 participants
Mar 7, 2024
Interventional
Conditions
Summary
To determine the dose duration-response using betamethsone ointment in healthy volunteers who demonstrate adequate vasoconstriction to topical steroids.
Eligibility
Inclusion Criteria7
- Males or females
- In good general health
- Show a vasoconstriction response to a single dose of betamethasone ointment
- Aged between 18-55 years of age inclusive
- BMI between 18 and 33 inclusive
- Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator
- Normal ECG
Exclusion Criteria12
- Clinically significant hypertension or circulatory disease and any clinically significant illness during the last four weeks prior to the entry into this study.
- Caffeine intake greater than 500 mg per day prior to this study.
- Who have been on a special diet, especially a low salt and/or fluid diet, during the 2 weeks prior to the first study day.
- Use of topical Dermatologic drug therapy on ventral forearms.
- Adverse reactions to topical or systemic corticosteroids.
- Who require shaving of the ventral forearms.
- Use of any vasoactive medication, prescription or over the counter that could modulate blood flow.
- Use of any prescription medication within 2 weeks preceding entry into the study
- Any obvious difference in skin colour between arms or any scarring on the forearms.
- Females who are pregnant or lactating
- Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk
- Participation in any drug or medical device study within 30 days of entering this study
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Interventions
A multiple dose study design whereby each participant receives 10 mg (5mg/cm2) per site of the test formulation of betamethasone ointment (0.05% w/w) and 10 mg (5mg/cm2) per site of the innovator formulation of betamethasone ointment (0.05% w/w) . The composition of the test and innovator formulations will be the same except for the excipients of each formulation. The intervention for this trial is the test formulation of 0.5 mg/g (0.05% w/w) betamethasone ointment. Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of betamethasone ointment (0.05% w/w) The test and reference ointment will be applied to pre-allocated sites at times determined from the pilot study results (ACTRN12623001179628). ED50 (optimal dose duration) D1 (Shorter dose duration reference listed drug calibrator) D2 (Longer dose duration reference listed drug calibrator) The ointment is then removed from all sites 5 hours after the first application and the Chromameter measurements for the pharmacodynamic responses of the topical corticosteroid will be carried out at 0, 2, 4, 6, 19 and 24 hours following removal. There will be 16 sites in total (8 on each arm whereby 6 sites will be treated with the test or reference cream and 2 sites will be untreated control sites). All application times will be recorded and checked in individual subjects Case Report Forms. Ointment is applied by a trained staff member using pre-filled applicators. Subjects who meet the inclusion and exclusion criteria will be included in this study. Pre and post study laboratory tests will be performed along with an ECG and medical evaluation. A follow up visit will also be completed to assess for safety.
Locations(1)
View Full Details on ANZCTR
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ACTRN12624000107527