Bioequivalence Study of Ivabradine 15 mg prolonged release tablet in healthy human male subjects
- Registration Number
- CTRI/2017/08/009520
- Lead Sponsor
- Abbott Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method