Bioequivalence study of Fingolimod 0.5 mg capsules
- Registration Number
- CTRI/2012/05/002703
- Lead Sponsor
- MSN Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
(i)Healthy, Indian, male, human volunteer aged from 18 to 45 years.
(ii)Body Mass Index (BMI) should be within 18.0-25.0 kg/m2.
(iii)Voluntarily willing and capable to give written and signed informed consent prior to participation in the study, according to the form attached in appendix 1.
(iv)Availability for the entire study period and willingness to adhere to protocol and study requirements.
(v)Volunteers willing to undergo pre and post-study physical examinations and laboratory investigations.
(vi)Having no significant disease or abnormal laboratory values on laboratory examination with no clinical relevance, medical history or physical examination during screening.
(vii)12-lead ECG in resting position and vital signs are within normal limits or showing or abnormalities, which the investigator does not consider of clinical relevance.
(viii)Normal chest X-Ray findings or findings that have no clinical correlation.
(ix)Non-smokers [Non-smokers at least 6 months from the day of screening].
(x)Having not consumed alcohol at least 48 hours prior to the study justified by negative breath-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study.
(xi)Negative urine test for drug of abuse (Amphetamine, barbiturate, tetrahydrocanabinoids, morphine, cocaine and benzodiazepine).
(i)History of allergy or sensitivity to fingolimod or history of any drug hypersensitivity or intolerance, which, in the opinion of the investigator, would compromise the safety of the volunteer if included in the study.
(ii)History of diseases of liver or hepatic impairment within last one (1) year.
(iii)Elevated serum transaminases (SGOT/ SGPT) or alkaline phosphatase. (at least 1.5 times of upper normal range).
(iv)History of mania or hypomania
(v)Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration.
(vi)Participation in another clinical study or a blood donation program or have had blood loss of more than 350 ml.
(vii)Renal failure (Serum creatinine more than twofold of the > 3 mg/dL).
(viii)Positive blood test for HIV, HbsAg, HCV or VDRL.
(ix)Any clinically relevant abnormality (to be determined by the investigator) following review of screening laboratory data and full physical examination.
(x)Vital sign abnormalities (systolic blood pressure in supine position lower than 100 or higher than 140 mm Hg or diastolic blood pressure lower than 60 or higher than 100 mm Hg or heart rate less than 55 bpm or more than 120 bpm) at screening and at pre-admission physical examination.
(xi)Evidence of second degree or higher AV block, sick sinus syndrome, prolonged QT interval, ischemic cardiac disease, or congestive heart failure in the 12-lead ECG is resting supine position.
(xii)Having suffered any illness within a week of starting the study or who have been hospitalized within the last 3 months preceding the start of the study.
(xiii)Having taken over the counter (OTC) or prescribed medications, including any antihypertensive drugs, enzyme-modifying drugs or any systemic medication within the 07 days prior to the study (However, paracetamol may be permitted up to 03 days prior to the start of the study).
(xiv)Have a history of substance abuse within the last 5 years.
(xv)Consumption of xanthine-containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hrs before IMP administration and grapefruit or orange juice for at least 48 hrs prior to IMP administration.
(xvi)Habit of chewing or inhaling nicotine-containing products (e.g. tobacco) currently or within last six months prior to the study.
(xvii)Abnormal INR combined with clinical manifestation
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method