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Clinical Trial Details

Trial ID: L3001
Source ID: NCT03686722
Associated Drug: Metformin
Title: Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Hepatitis C|Drug Interactions
Interventions: DRUG: Metformin|DRUG: Daclatasvir
Outcome Measures: Primary: (AUC0→12), Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml), From first sampling interval(time zero) up to 12 hours|Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞), Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml), From first sampling interval up to infinity|Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau), Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml), From first sampling interval up to dosing interval(Tau)|Maximum drug concentration in plasma at steady state(Cpss), Maximum drug concentration in plasma at steady state measured in (ng/ml), Time corresponding to maximum drug concentration in plasma at steady state|Half life( t½) of drug in plasma, Half life of drug measured in Hours(hr), Up to 12 hours|Mean residence time of drug(MRT), Mean residence time of drug in plasma measured in (hr), From first sampling interval up to 12 hours|steady state Clearance of drug(CLss), steady state Clearance of drug measured in (ml/min), From first sampling interval up to 12 hours|Renal Clearance of drug(CLr), Renal Clearance of drug measured in (ml/min), From first sampling interval up to 12 hours|Cumulative amount of drug eliminated in urine (Ae), Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml), From first sampling interval up to 12 hours|Maximum excretion rate (Urate max), Maximum excretion rate for the drug measured in (milligram(mg)/hr), From first sampling interval up to 12 hours | Secondary: Blood Glucose(BG) levels, Blood glucose levels measured in (mg/dl), up to 3 hours|Area under the BG-time curve(AUG)0-3hr, Area under the BG-time curve measured in (mg.hr/dl), up to 3 hours|Maximum Glucose concentration(Gmax), Maximum Glucose concentration measured in (mg/dl), up to 3 hours
Sponsor/Collaborators: Sponsor: Mohamed Raslan | Collaborators: Ain Shams University|Drug Research Centre, Cairo, Egypt
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2017-09-09
Completion Date: 2017-12-06
Results First Posted:
Last Update Posted: 2018-10-12
Locations: Drug research centre, Cairo, Egypt
URL: https://clinicaltrials.gov/show/NCT03686722