CTRI/2017/08/009520 [Registered on: 28/08/2017] Trial Registered Retrospectively
Last Modified On:
11/09/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence Study of Ivabradine 15 mg prolonged release tablet in healthy human male subjects
Scientific Title of Study
A pilot, open-label, balanced, randomized, fourperiod,
two-sequence, two-treatment cross-over
study to study the relative bioavailability of test
Ivabradine prolonged release tablets (15 mg)
given once a day versus Coralan® film-coated
tablets (7.5 mg) twice a day at 12 hours apart
under fasting and fed conditions in healthy
human male subjects
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol Version 2, dated 06 June 2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Adarsh Kumar Garg
Designation
Principal Investigator
Affiliation
Lambda Therapeutic Research Ltd
Address
Clinical Department,
Lambda Therapeutic Research Ltd.,
Lambda house, Plot no.38, Survey no. 388,
Near Silver Oak Club, S. G. Highway, Gota,
Ahmedabad 382481,Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
07940202020
Fax
07940202021
Email
adarshgarg@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Adarsh Kumar Garg
Designation
Principal Investigator
Affiliation
Lambda Therapeutic Research Ltd
Address
Clinical Department,
Lambda Therapeutic Research Ltd.,
Lambda house, Plot no.38, Survey no. 388,
Near Silver Oak Club, S. G. Highway, Gota,
Ahmedabad 382481,Gujarat, India
GUJARAT 382481 India
Phone
07940202020
Fax
07940202021
Email
adarshgarg@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Shubhangi Desai
Designation
Associate Director, Clinical Operations and Pharmacovigilance
Affiliation
Abbott Healthcare Pvt. Ltd.
Address
Department: Clinical Operations, Medical Affairs, Floor 16, Godrej BKC, Plot No. C68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India Mumbai MAHARASHTRA 400051 India
Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Adarsh Kumar Garg
Lambda Therapeutic Research Ltd
Clinical Department, Lambda house, Plot no. 38, Survey no. 388,
Near Silver Oak Club, S. G. Highway, Gota,
Ahmedabad - 382481, Gujarat, India. Ahmadabad GUJARAT
Healthy adult human male subjects between 18 and 45 years of age (both inclusive) with no hypersensitivity or idiosyncratic reaction to Ivabradine or any other similar/ related drugs.
Each film-coated tablet contains Ivabradine hydrochloride equivalent to Ivabradine 7.5 mg Oral Tablet twice a day at 12 hours apart to be administered to each subject in each period.
Intervention
Ivabradine 15 mg Oral prolonged release tablet
Each film coated prolonged release tablet contains Ivabradine Hydrochloride Equivalent to Ivabradine 15 mg oral tablet once a day at 12 hours apart to be administered to each subject in each period.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
a)Non smoker, non-alcoholic, healthy adult human male subjects between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
b)Having a Body Mass Index (BMI) between 18.5 and 30 (both inclusive), calculated as weight in kg / height in m2.
c)Subject weight should be more than 50 kg at the time of screening.
d)Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (Postero-anterior view) recordings.
e)Able to understand and willing to comply with the study procedures, in the opinion of the Principal investigator.
f)Subjects who are able and willing to give written informed consent.
ExclusionCriteria
Details
a)Known hypersensitivity or idiosyncratic reaction to Ivabradine or any other similar/ related drugs.
b)History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
c)Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 70 or more than 100 beats per minute at the time of screening
d)Presence of orthostatic hypotension.
e)If the QTc interval will be more than 450 ms on ECG measurement at the time of screening.
f)History of major surgery within 4 weeks prior to receiving study medicine in period-I.
g)Ingestion of a medication (including prescribed and/or non-prescribed, systemic and/or topical medication including herbal supplements/medicines) at any time within14 days prior to dosing of Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
h)Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
i)A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine in period-I.
j)Smokers, or who have smoked within last six months prior to start of the study.
k)Consumption of grapefruit or grapefruit products within a period of 72 hours prior to dosing in period-I.
l)The presence of clinically significant abnormal laboratory values during screening.
m)Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
n)History or presence of psychiatric disorders.
o)A history of difficulty in donating blood.
p)Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of study medicine. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
Note: In case the blood loss was less than or equal to 200 mL; subject may be enrolled 60 days after blood donation or after the last sample of previous study.
q)A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
r)A positive test result for HIV (I & II) antibody.
s)An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IMP in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To study relative bioavailability after single oral administration of once daily test product versus twice oral administration of reference product at 12 hours apart under fasting and fed conditions in healthy human male subjects.
The venous blood samples to be withdrawn pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.500, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 12.250, 12.500, 12.750, 13.000, 13.333, 13.667, 14.000, 14.500, 15.000, 16.000, 18.000, 20.000, 22.000, 24.000, 36.000 and 48.000 hours post-dose following drug administration in each period.
Secondary Outcome
Outcome
TimePoints
To assess the safety and tolerability of Ivabradine following single oral administration of once daily test product versus twice oral administration of reference product at 12 hours apart in healthy human male subjects.
The venous blood samples will be withdrawn pre-dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.500, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 12.250, 12.500, 12.750, 13.000, 13.333, 13.667, 14.000, 14.500, 15.000, 16.000, 18.000, 20.000, 22.000, 24.000, 36.000 and 48.000 hours post-dose following drug administration in each period.
Target Sample Size
Total Sample Size="14" Sample Size from India="14" Final Enrollment numbers achieved (Total)= "14" Final Enrollment numbers achieved (India)="14"
Phase of Trial
Phase 1
Date of First Enrollment (India)
07/10/2016
Date of Study Completion (India)
05/11/2016
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
None
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is being conducted to study relative bioavailability after single oral administration of once daily Ivabradine prolonged release tablet 15 mg versus twice oral administration of Coralan® 7.5 mg (Ivabradine Hydrochloride) Tabletsat 12 hours apart under fasting and fed conditions in healthy human male subjects.
The study shows that Test Product-T
when compared to the Reference Product-R, meets the relative bioavailability criteria with respect to AUC0-t and AUC0-∞ for Ivabradine under fasting and fed conditions and also demonstrated that the test and the reference products were well tolerated. There were no AEs during the conduct of the study.