An open-label, randomized, single-dose, two-treatment, single period, parallel- group bioequivalence study of Fingolimod 0.5 mg capsules manufactured by MSN Laboratories Limited, India (Test) with GILENYAâ„¢ capsules containing fingolimod 0.5 mg manufactured by Novartis Pharmaceuticals Corporation, U.S.A. (Reference), in healthy, adult, male, human subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To evaluate the bioequivalence between two formulations i.e. Fingolimod 0.5 mg capsules manufactured by MSN Laboratories Limited, India (Test) and GILENYAâ„¢ capsules containing fingolimod 0.5 mg manufactured by Novartis Pharmaceuticals Corporation, U.S.A. (Reference), following single dose of three capsules of test or reference formulation in healthy, adult, male, human subjects under fasting condition by means of rate and extent of absorption.
研究概览
简要总结
Single-dose, randomized, open-label, two-treatment, single period,parallel-group bioequivalence studyin the healthy, adult, male, human subjects under fasting condition is employed to evaluate the bioequivalence between twoformulations i.e. Fingolimod 0.5 mgcapsules manufactured by MSN Laboratories Limited, India (Test) and GILENYA™capsules containing fingolimod 0.5 mg manufactured by Novartis Pharmaceuticals Corporation,U.S.A. (Reference), following single dose of three capsules of test orreference formulation in healthy, adult, male, human subjects under fastingcondition by means of rate and extent of absorption and monitor the safety of the participants. Blood will be collected at twenty-one (21) timepoints, (5 mL each) in K3EDTAvacutainers in this single period study at following time points: 0.00 (predose), 1.00, 2.00,4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00,96.00, 144.00, 192.00, 240.00, 288.00, 336.00 and 432.00 hours after IMP administration. Allthe collected blood samples will be divided into two suitably pre-labelled transparent polypropylene cryovials and stored immediately at-80° ± 10°C in the bioanalytical department. Each tube or cryovial willhave at least 2.5 mL of blood. After completion of the study, segregation of aliquotswill be done in the bioanalytical department under controlled temperatureconditions [using dry ice etc.] to avoid thawing. Samples from allevaluable subjects who complete the study will be assayed for only fingolimod. All the samples will be transferred from theclinical to the analytical facility after completion of the study. Theanalytical unit is responsible for accurate and precise quantification of fingolimod during analysis, quality control samples will bedistributed throughout each batch of study samples. The analyst will not haveaccess to the randomisation schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •(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/m
- •(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
- •(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).
排除标准
- •(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.
- •(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.
结局指标
主要结局
To evaluate the bioequivalence between two formulations i.e. Fingolimod 0.5 mg capsules manufactured by MSN Laboratories Limited, India (Test) and GILENYAâ„¢ capsules containing fingolimod 0.5 mg manufactured by Novartis Pharmaceuticals Corporation, U.S.A. (Reference), following single dose of three capsules of test or reference formulation in healthy, adult, male, human subjects under fasting condition by means of rate and extent of absorption.
时间窗: 0.00 (predose), 1.00, 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 144.00, 192.00, 240.00, 288.00, 336.00, and 432.00 hours after IMP administration
次要结局
- To monitor the safety of the participating subjects in this bioequivalence study of Fingolimod 0.5 mg capsules manufactured by MSN Laboratories Limited, India (Test) and GILENYAâ„¢ capsules containing fingolimod 0.5 mg manufactured by Novartis Pharmaceuticals Corporation, U.S.A. (Reference) formulation, determined by means of clinical biochemistry, physical examination and AE/SAE monitoring(throughout the study)