NCT01089179已完成1 期
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fed 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: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed condition.
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 subjects who qualify for the study should meet the following inclusion criteria.
- •Male subjects in the range of 18 - 45 years of age.
- •Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- •Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
- •Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
- •Willingness to follow the protocol requirement as evidenced by written, informed consent.
- •Agreeing to, not using any medication (prescription and over the counter), including vitamins and minerals for two weeks prior to study & during the course of the study.
- •No history or presence of significant alcoholism or drug abuse in the past one year.
- •Non-smokers, ex smokers and light smokers will be included. " Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.
排除标准
- •The subjects who qualify for the study should not meet the following exclusion criteria:
- •Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: selective serotonin reuptake inhibitors (SSRIs), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- •History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
- •Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- •History of malignancy or other serious diseases.
- •Refusal to abstain from food for ten (10) hours prior to study drug administration on first day of each study period and for four (4) additional hours each, post dose.
- •Refusal to abstain from water for one hour pre dose and for two (2) hours, post dosing.
- •Any contraindication to blood sampling.
- •Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period. Habituation of tobacco necessitating uninterrupted tobacco consumption.
- •Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
- •Blood donation 90 days prior to the commencement of the study.
- •Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
- •Known history of allergic reactions to Metformin or other related drugs.
- •History of drug abuse in the past one year.
- •Use of prescription medication or over the counter products (including natural food supplements,vitamins, garlic as a supplement) within 2 weeks prior to administration of study medication, except for topical products without systemic absorption.
研究组 & 干预措施
Torrent's Metformin tablets 500 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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