NCT03517020已完成1 期
An Open Label, Randomized, 2-Period, 2- Treatment, 2 -Sequence, Crossover, Single-Dose BE Study of Nebivolol 20 mg Tablet [Torrent, India]Versus Bystolic® 20 mg Tablet [ Forest Pharmaceuticals Inc., USA] in Healthy Subjects - Fasted.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Cmax
研究概览
简要总结
Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
详细描述
An Open Label, Randomized, 2 -period, 2 -Treatment, 2 Sequence, Crossover, Single-dose Bioequivalence Study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fasting Condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sex: male
- •Age: 18-45 years (inclusive both)
- •Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- •Healthy and willing to participate in the study.
- •Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- •Non-smokers or smoker who smokes less than 10 cigarettes per day.
排除标准
- •Inability to communicate or co-operate.
- •Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- •History of pre-existing bleeding disorder.
- •Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- •Clinically significant abnormal ECG or Chest X-ray.
- •HIV, HCV, HBsAg positive volunteers.
- •History of significant blood loss due to any reason, including blood donation in the past 3 months.
- •Participation in any study within past 3 months before entry to the study,
- •History of alcohol or drug abuse.
- •History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
- •Positive to breath alcohol test.
- •Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- •Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 50/minute or more than 100/minute.
- •Oral temperature less than 95°F or more than 98.6°F.
- •Respiratory rate less than 12/minute or more than 20/minute.
- •History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- •Recent History of kidney or liver dysfunction.
- •Volunteers suffering from any psychiatric (acute or chronic) disorder.
- •Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
研究组 & 干预措施
Test
Experimental
Torrent's Nebivolol Tablets 20 mg
干预措施: Torrent's Nebivolol Tablets (Drug)
Reference
Active Comparator
Forest Pharmaceuticals Inc.'s Bystolic® Tablets 20 mg
干预措施: Forest Pharmaceuticals Inc's Bystolic Tablets (Drug)
结局指标
主要结局
Cmax
时间窗: pre-dose to 8 hours post-dose
AUC
时间窗: pre-dose to 8 hours fasting post-dose
次要结局
未报告次要终点
研究者
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