Study of absorption and elimination rate of Dimethyl Fumarate 240-mg capsule in comparison with Dimethyl Fumarate brand Capsule (Tecfidera®).
Not Applicable
- Conditions
- Bioequivalence study.
- Registration Number
- IRCT20200407046981N27
- Lead Sponsor
- Avicenna Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
The weight limit of each volunteer should be between 60 and 100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Candidates who have consented to the consent form.
Exclusion Criteria
Known hypersensitivity or idiosyncratic reaction to Dimethyl Fumarate or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two weeks before dosing.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method