CTRI/2012/05/002703 [Registered on: 28/05/2012] Trial Registered Prospectively
Last Modified On:
05/03/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Bioequivalence study of Fingolimod 0.5 mg capsules
Scientific Title of Study
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.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
LBS-PRO-008-11, Version 02, dated 12-Apr-12
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mukund Zarapkar
Designation
Vice President - Clinical Research
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Address
Centaur House, Near Hotel Grand Hyatt, Vakola, Santacruz [East], Mumbai 400055
Mumbai MAHARASHTRA 400055 India
Phone
912266499154
Fax
912266499239
Email
drzarapkar@lifesan.in
Details of Contact Person Scientific Query
Name
Dr Mukund Zarapkar
Designation
Vice President - Clinical Research
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Address
Centaur House, Near Hotel Grand Hyatt, Vakola, Santacruz [East], Mumbai 400055
MAHARASHTRA 400055 India
Phone
912266499154
Fax
912266499239
Email
drzarapkar@lifesan.in
Details of Contact Person Public Query
Name
Dr Mukund Zarapkar
Designation
Vice President - Clinical Research
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Address
Centaur House, Near Hotel Grand Hyatt, Vakola, Santacruz [East], Mumbai 400055
LifeSan Clinical Research, Centaur House, Near Hotel Grand Hyatt, Vakola, Santacruz [East], Mumbai, 400055 Mumbai MAHARASHTRA
912266499154 912266499239 drzarapkar@lifesan.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Alert EC-IEC
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Fingolimod would be used in the treatment of multiple sclerosis
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fingolimod 0.5 mg capsules manufactured by MSN Laboratories Limited, India
Single dose of three capsules of 0.5 mg fingolimod will be administered along with 240 mL water after volunteers have fasted for 11 hours prior to dosing
Single dose of three capsules of GILENYAâ„¢ capsules containing fingolimod 0.5 mgwill be administered along with 240 mL water after volunteers have fasted for 11 hours prior to dosing
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
(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).
ExclusionCriteria
Details
(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
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
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
Target Sample Size
Total Sample Size="32" Sample Size from India="32" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="32"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Single-dose, randomized, open-label, two-treatment, single period,
parallel-group bioequivalence study
in the healthy, adult, male, human subjects under fasting condition is employed 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 and monitor the safety of the participants. Blood will be collected at twenty-one (21) timepoints, (5 mL each) in K3EDTA
vacutainers in this single period studyat 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 hoursafter IMP administration. All
the 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 will
have at least 2.5 mL of blood. After completion of the study, segregation of aliquots
will be done in the bioanalytical department under controlled temperature
conditions [using dry ice etc.] to avoid thawing. Samples from all
evaluable subjects who complete the study will be assayed for only fingolimod. All the samples will be transferred from the
clinical to the analytical facility after completion of the study. The
analytical unit is responsible for accurate and precise quantification of fingolimod during analysis, quality control samples will be
distributed throughout each batch of study samples. The analyst will not have
access to the randomisation schedule.