Comparative assessment of the absorption of a generic formulation of dimethyl fumarate capsule against the innovator dimethyl fumarate capsule conducted under fasting condition in healthy male and female volunteers.
- Conditions
- Dimethyl fumarate is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.Neurological - Multiple sclerosis
- Registration Number
- ACTRN12619000576123
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 32
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Concomitant drug therapy of any kind
Any clinically significant medical conditions
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method