CTRI/2017/08/009520已完成1 期
A pilot, open-label, balanced, randomized, fourperiod,two-sequence, two-treatment cross-overstudy to study the relative bioavailability of testIvabradine prolonged release tablets (15 mg)given once a day versus Coralan® film-coatedtablets (7.5 mg) twice a day at 12 hours apartunder fasting and fed conditions in healthyhuman male subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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) Tablets at 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated 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
- •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 m
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)
研究者
研究点 (1)
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