Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma for Pharmaceuticals & Medical Appliances, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands) After a Single Oral Dose Administration of Each to Healthy Adults Under Fed Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
详细描述
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. All dosed subject samples will be analyzed and their data will be included in the final study report.
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.
The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, age 18 to 55 years, inclusive.
- •Body weight within 15% of normal range (18.5-30.0) according to the accepted normal values for body mass index (BMI).
- •Medical demographics without evidence of clinically significant deviation from normal medical condition, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
- •Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- •Females should be on a suitable birth control method.
- •Fully informed subjects that consented to participate in the study.
排除标准
- •Subjects with known allergy to the products tested.
- •Subjects who meet any of the contraindications to the administration of Sitagliptin and/or Metformin HCl.
- •Subjects who are going to get an injection of dye or contrast agents for an x-ray procedure.
- •Subject does not agree not to consume any medication or food which may affect CYP3A4 enzyme at least one week prior to first study drug administration until donating the last sample of the study.
- •Subjects that do not agree not to consume alcohol-containing beverages and foods for 1 week before dosing and throughout the period of sample collection.
- •Heavy smokers.
- •Female subjects who were pregnant or nursing.
- •Acute infection within one week preceding first study drug administration.
- •History of drug or alcohol abuse.
- •Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- •Subject is on a special diet (for example subject is vegetarian).
- •Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
- •Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
- •Subject has a family history of severe diseases which have direct impact on the study.
- •Participation in a bioequivalence study or in a clinical study within the last 60 days, before first study drug administration.
- •Subject intends to be hospitalized within 3 months after first study drug administration.
- •Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.
研究组 & 干预措施
T test
1 tablet contains 1000 mg Metformin HCl & 50 mg Sitagliptin orally administrated with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing
干预措施: Gleptomet 50/1000(Metformin HCl & Sitagliptin) (Drug)
R Reference
1 tablet contains 1000 mg Metformin HCl & 50 mg Sitagliptin orally administrated with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing
干预措施: Janumet 50/1000(Metformin HCl & Sitagliptin) (Drug)
结局指标
主要结局
Cmax
时间窗: Up to 36 hours post dose in each treatment period
to measure the maximal measured plasma concentration
次要结局
- Tmax(Up to 36 hours post dose in each treatment period)