NCT01218711已完成1 期
An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Fixed Dose Combination (FDC) of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fasting Conditions.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- Bioequivalence based AUC parameters
研究概览
简要总结
Objective:
to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck & Co., Inc.
Study Design:
Randomized, Two-Way Crossover, Single-Dose, Open-Label in 70 healthy human adult subjects
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The volunteers were excluded from the study based on the following criteria:
- •Sex: male.
- •Age: 18 - 45 years. .
- •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
- •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 100 mm Hg or more than 140 mm Hg 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°P or more than 98.6°P.
- •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.
- •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.
结局指标
主要结局
Bioequivalence based AUC parameters
Bioequivalence based on Cmax
次要结局
未报告次要终点
研究者
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