Relative bioavailability of fingolimod (2Ã?0.25 mg) vs. FMI, 0.5 mg capsule in healthy volunteers
Phase 1
Completed
- Registration Number
- CTRI/2012/01/002326
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
Inclusion Criteria
1. Healthy subjects
2. Female subjects must be of non-child bearing potential
3. Subjects must weigh at least 50 kg and their BMI should be within range of 18-30 kg/m2
Exclusion Criteria
1. Smokers
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Pregnant or nursing (lactating) women
4. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
5. History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method