Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetics and Pharmacodynamics of Metformin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- (AUC0→12)
研究概览
简要总结
A Randomized,Two-period, Crossover Study to Determine the Possibility of Drug-drug Interaction After Co-administration of Metformin and Daclatasvir Where Twenty Eligible Adult Subjects Will be Randomized to Receive Either Metformin Only and/or Metformin Co-administered With Daclatasvir to measure primary outcomes including pharmacokinetics parameters as: Maximum drug concentration in plasma(Cmax), Area under the Plasma concentration Versus Time Curve from time 0 to 12 hours(AUC0-12), Clearance(CL)
详细描述
Study Design:
A randomized, one-way, single blinded, two-period, crossover study in adult human healthy egyptian volunteers
Methodology:
period (I): Group A:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7
GroupB:10 volunteers will receive 500 mg Metformin twice daily + Daclatasvir (DCV) 60 mg once daily on day 1-4 then 1000mg metformin twice daily+DCV 60 mg once daily on day 5-7
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18-55 years at screening.
- •Subject has a Body Mass Index of 18 to 35 kg/m
- •Subject are non smokers or moderate smokers(not more than 10 cigarettes per day)
- •Subjects is willing to participate and give their final written consent prior to the commencement of the study procedures
- •Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.
- •Subject has a normal blood pressure and pulse rate, according to the reference normal ranges.
排除标准
- •Treatment with any known enzyme-inducing/inhibiting agents prior to the start of the study and throughout the study.
- •Subjects who have taken any medication two weeks preceding of the trial starting date.
- •Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- •Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- •Gastrointestinal diseases.
- •Renal diseases.
- •Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .
- •Pancreatic disease including diabetes.
- •Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases
- •Hematological disease or pulmonary disease
- •Abnormal laboratory values.
- •Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.
- •Positive HIV test.
- •History of or current abuse of drugs, alcohol or solvents.
- •Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extrahepatic tumors
- •Autoimmune disorders as Graves disease
- •Central nervous system (CNS) disorders
研究组 & 干预措施
Metformin
Subjects administered Metformin 500mg(Glucophage tablets) twice daily till day(4) then Metformin 1000mg twice daily till day(7)
干预措施: Metformin (Drug)
Metformin and Daclatasvir
Subjects Coadministered Metformin 500mg(Glucophage tablets) twice daily and Daclatasvir 60mg tablets once daily till day (4) then Metformin 1000mg twice daily and Daclatasvir 60mg tablets once daily till Day(7)
干预措施: Metformin (Drug)
Metformin and Daclatasvir
Subjects Coadministered Metformin 500mg(Glucophage tablets) twice daily and Daclatasvir 60mg tablets once daily till day (4) then Metformin 1000mg twice daily and Daclatasvir 60mg tablets once daily till Day(7)
干预措施: Daclatasvir (Drug)
结局指标
主要结局
(AUC0→12)
时间窗: From first sampling interval(time zero) up to 12 hours
Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞)
时间窗: From first sampling interval up to infinity
Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml)
Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau)
时间窗: From first sampling interval up to dosing interval(Tau)
Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml)
Maximum drug concentration in plasma at steady state(Cpss)
时间窗: Time corresponding to maximum drug concentration in plasma at steady state
Maximum drug concentration in plasma at steady state measured in (ng/ml)
Half life( t½) of drug in plasma
时间窗: Up to 12 hours
Half life of drug measured in Hours(hr)
Mean residence time of drug(MRT)
时间窗: From first sampling interval up to 12 hours
Mean residence time of drug in plasma measured in (hr)
steady state Clearance of drug(CLss)
时间窗: From first sampling interval up to 12 hours
steady state Clearance of drug measured in (ml/min)
Renal Clearance of drug(CLr)
时间窗: From first sampling interval up to 12 hours
Renal Clearance of drug measured in (ml/min)
Cumulative amount of drug eliminated in urine (Ae)
时间窗: From first sampling interval up to 12 hours
Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml)
Maximum excretion rate (Urate max)
时间窗: From first sampling interval up to 12 hours
Maximum excretion rate for the drug measured in (milligram(mg)/hr)
次要结局
- Blood Glucose(BG) levels(up to 3 hours)
- Area under the BG-time curve(AUG)0-3hr(up to 3 hours)
- Maximum Glucose concentration(Gmax)(up to 3 hours)
研究者
Mohamed Raslan
Principal Investigator
Ain Shams University