CTRI/2020/02/023327已完成不适用
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of trimetazidine dihydrochloride extended release capsules 80 mg (Trade Name FLAVEDON OD) OF SERDIA PHARMACEUTICALS PVT. LTD., INDIA comparing with Vastarel® OD 80 MG prolonged release hard capsule (TRADE NAME VASTAREL® OD 80 MG) OF EGIS PHARMACEUTICALS PLC, Hungary, in normal, healthy, adult, human male subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s test product [Trimetazidine Dihydrochloride Extended Release Capsules 80 mg (Trade name FLAVEDON OD)] relative to that of reference product [VASTAREL® OD 80 mg Prolonged Release Hard Capsule (Trade name VASTAREL® OD 80 mg)] after single oral dose administration in normal, healthy, adult, human male subjects under fasting condition and to demonstrate the bio-equivalence between both treatments.
研究概览
简要总结
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s test product [Trimetazidine Dihydrochloride Extended Release Capsules 80 mg (Trade name FLAVEDON OD)] relative to that of reference product [VASTAREL® OD 80 mg Prolonged Release Hard Capsule (Trade name VASTAREL® OD 80 mg)] after single oral dose administration in normal, healthy, adult, human male subjects under fasting condition and to demonstrate the bioequivalence between both treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Non-smokers, normal, healthy, adult, human male volunteers between 18 to 45 years of age (both inclusive).
- •2.Having a Body Mass Index (BMI) ranging within18.5 to 30.0 (both inclusive), calculated as weight in kg / height in m
- •3.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 (P/A view) recordings.
- •4.Able to understand and comply with the study procedures, in the opinion of the investigator.
- •5.Able to give voluntary written informed consent for participation in the study.
排除标准
- •1.Known hypersensitivity to Trimetazidine or any excipients or any related drug or any substance.
- •2.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.
- •3.Ingestion of a medication (prescribed & over the counter (OTC) medication including herbal remedies) at any time within 14 days prior to check-in in period-I.
- •In any such case subject selection will be at the discretion of the Principal Investigator / designee.
- •4.Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •5.Subject having CrCL ≤ 60 ml/min at screening.
- •6.A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men (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 check-in of period-I.
- •7.Smokers or who have smoked within last 06 months prior to start of the study.
- •8.The presence of clinically significant abnormal laboratory values during screening.
- •9.Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •10.A history of difficulty with donating blood.
- •11.Difficulty in swallowing solid dosage forms like tablets or capsules.
- •12.Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication (If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received) 14.A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •16.Consumption of grape fruit or grape fruit products within 72 hours prior to check-in of period-I.
- •17.An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to check-in in period-I.
结局指标
主要结局
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s test product [Trimetazidine Dihydrochloride Extended Release Capsules 80 mg (Trade name FLAVEDON OD)] relative to that of reference product [VASTAREL® OD 80 mg Prolonged Release Hard Capsule (Trade name VASTAREL® OD 80 mg)] after single oral dose administration in normal, healthy, adult, human male subjects under fasting condition and to demonstrate the bio-equivalence between both treatments.
时间窗: Day 1: Day of dosing. | Day 2, 3, 4: Subsequent days after dosing.
次要结局
- To monitor the safety of the subjects(Day 4)
研究者
研究点 (1)
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