NCT01089192已完成1 期
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fasting Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
Objective:
To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fasting Conditions.
Study Design:
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study
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
- •Volunteers must meet all of the following criteria in order to be included in the study:
- •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 a day.
排除标准
- •The volunteers will be 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°F or more than 98.6°F.
- •Respiratory rate less than 12/minute or more than 20/minute
- •Addiction to alcohol or history of any drug abuse within the past 2 years.
- •Recent History of kidney or liver dysfunction.
- •History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- •Administration/ Intake of prescription or OTC medication for two weeks before the study.
- •Patients suffering from any chronic illness such as arthritis, asthma etc.
- •HIV, HCV, HBsAg positive volunteers.
- •Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive volunteers based on urine test.
- •Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- •Administration of any investigational products in the period 0 to 3 months before entry to the study.
- •Intake of barbiturates or any enzyme-inducing drug in last three months.
- •History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
- •Existence of any surgical or medical condition, which, in the judgement of the Chief Investigator and/or clinical investigator, 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
Torrent's Metformin tablets 750 mg
Experimental
干预措施: Metformin (Drug)
Glucophage XR® of Bristol- Myers Squibb Company, USA)
Active Comparator
干预措施: Metformin (Drug)
研究者
研究点 (1)
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