An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesaartan Medoxomil, Amlopdipine and Hydrochlorothiazide (40+10+25) mg Tab [Torrent,India] Vs Tribenzor(40+10+25) mg Tab [ Daichi Sankyo, Inc USA] in Healthy Subjects-Fasted Condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Cmax
研究概览
简要总结
Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.
详细描述
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of FDC of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo 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
- •Volunteer with BMI of 18-25 (inclusive both) kg/m2
- •Healthy and willing to participate in the study.
- •Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- •Preferably Non-smokers
排除标准
- •The volunteers were excluded from the study based on the following criteria:
- •Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- •Clinically significant abnormal ECG or Chest X-ray.
- •Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than 95°F or more than 99°F.
- •Respiratory rate less than 14/minute or more than 18/minute
- •History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- •History of alcohol or drug abuse
- •Positive breath alcohol test
- •Recent history of kidney or liver dysfunction.
- •History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
- •Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- •History of heart failure.
- •HIV, HCV, HBsAg positive volunteers.
- •Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- •Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- •Administration of any study drug in the period 0 to 3 months before entry to the study.
- •History of significant blood loss due to any reason, including blood donation in the past 3 months.
- •History of pre-existing bleeding 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.
- •Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
研究组 & 干预措施
Test
Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide (40+10+25) mg Tablets
干预措施: Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets (Drug)
Reference
Tribenzor (40+10+25) mg Tablets of Daichi Sankyo Inc, USA
干预措施: Tribenzor Tablets of Daichi Sankyo Inc, USA (Drug)
结局指标
主要结局
Cmax
时间窗: Pre-dose to 72 hours after post dose
AUC
时间窗: Pre-dose to 72 hours after post dose
次要结局
未报告次要终点