Four-way Crossover, Open-label, Single-dose, Bioequivalence Study of Metformin (LLC "GEROPHARM", Russia) 1000 mg Tablets Immediate Release (IR )Versus Glucophage® (Merck Sante S.A.S, France) 1000 mg Tablets IR in Normal Healthy Subjects Under Fasting and Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )
详细描述
Study to evaluate the bioequivalence of orally administered metformin preparations, immediate release tablets, 1 000 mg in normal healthy subjects under fasting and fed conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form.
- •Healthy male and female subjects aged 18 to 45 years.
- •Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- •Have a body mass index between 18,5 and 27 kg/m
- •Females must have a negative pregnancy test.
- •Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.
排除标准
- •History of serious allergic problems/events
- •Medicinal intolerance.
- •History of allergic reactions to memantine or investigator's product components
- •Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- •Acute infectious diseases in less than 4 weeks before the start of the study.
- •Subjects who have taken medication 4 weeks preceding before the study.
- •Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
- •Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
- •History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- •Participation in other clinical training is less than than for 3 months before the study.
- •Lack of signed informed consent form.
- •ECG or vital signs abnormalities (clinically significant).
- •Positive testing for alcohol, drugs, pregnancy.
- •Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
- •Any diet, for example, vegetarian, for 2 weeks before taking the study medications.
- •Women with preserved reproductive potential who have unprotected sexual intercourse with an unsterilized male partner within 30 days prior to taking the study medication.
- •Heart rate below 60 or above 80 beats per minute.
- •Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
- •Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.
研究组 & 干预措施
Metformin
First aIntervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition
Third Intervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition
干预措施: Metformin (Drug)
Glucophage®
Second Intervention Period:
Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fasting condition
Fourth Intervention Period:
Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fed condition
干预措施: Glucophage® (Drug)
结局指标
主要结局
Cmax
时间窗: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)
AUC(0-t)
时间窗: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
次要结局
未报告次要终点