Comparative bioequivalence study of a generic formulation of fingolimod capsule against the innovator fingolimod capsule in fasting healthy subjects
- Registration Number
- ACTRN12615001055594
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Healthy males and non-pregnant females
Aged between 18 and 45
Non-smoker
BMI between 18 and 25 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives
Sensitivity to fingolimod any other similar class medicines, excipients of fingolimod
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who have any eye problems or conditions especially inflammation of the eye
Who have had a clinical illness within 4 weeks prior to the start of the study
Who have received any vaccinations within 1 month prior to dosing
Females who are breastfeeding or are planning to start a family within 60 days of dosing
Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
Smoker (anyone who has smoked in the last 6 months)
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, 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 To compare the bioavailability of fingolimod (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for fingolimod using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[0, 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post dosing]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant.[0, 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post dosing]