None listed
Conditions
Brief summary
To determine the in vivo bioequivalence of two formulations of betamethasone OV ointment using the ED50, D1 (Shorter dose duration reference listed drug calibrator) and D2 (Longer dose duration reference listed drug calibrator) results calculated in the pilot dose duration-response study (ACTRN12623001181695)
Interventions
A multiple dose study design whereby each participant receives 10 mg (5mg/cm2) per site of the test formulation of betamethasone OV ointment (0.05% w/w) and 10 mg (5mg/cm2) per site of the innovator formulation of betamethasone OV 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 OV ointment.
Participants will
A multiple dose study design whereby each participant receives 10 mg (5mg/cm2) per site of the test formulation of betamethasone OV ointment (0.05% w/w) and 10 mg (5mg/cm2) per site of the innovator formulation of betamethasone OV 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 OV ointment. Participants will be healthy participants who have shown a vasoconstriction response to a single dose of betamethasone OV 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 (ACTRN12623001181695) . ED50 (optimal dose duration) - applied at approx 12.15pm D1 (Shorter dose duration reference listed drug calibrator) - applied at approx 12.45pm D2 (Longer dose duration reference listed drug calibrator) - applied at approx 11.30pm All site applications will be performed by trained staff and the on site Supervisor will ensure adherence to the intervention.. 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 ointment and 2 sites will be untreated control sites). All application times will be recorded and checked in individual participants Case Report Forms. Ointment is applied by a trained staff member using pre-filled applicators. Participants who meet the inclusion and exclusion criteria will be included in this study. Participants from the pilot study will be permitted to take part in this study as long as they meet all inclusion and exclusion criteria for this study including the requirement of a 30 day stand down period from previous participation. 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.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Males or females In good general health Show a vasoconstriction response to a single dose of betamethasone OV 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 criteria
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 participant at significant risk Participation in any drug or medical device study within 30 days of entering this study
Outcome results
None listed