- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03686722
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetics and Pharmacodynamics of Metformin
Study Overview
Status
Intervention / Treatment
Detailed Description
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
period (II): Group A: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
Group B:10 volunteers will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice daily on day 5-7
All drug administration will be followed by 240 ml of water after at least 10 hours fasting prior to administration.
The two treatment periods will be separated by a one week washout period
Blood Sampling will be collected at a pre-dosing and at 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12 hours Urine samples will be collected for metformin analysis from 0 to 12 hours after drug administration.
A 75 g Oral glucose tolerance test(OGTT) will be carried out by ingestion of 75g glucose in 240ml water 2-hours post dosing and blood samples for determining glucose concentration during OGTTs were collected immediately before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, and 3 hours after glucose ingestion.
Blood samples will be collected from each volunteer prior to drug administration (blank) at the predetermined sampling intervals after drug administration in ethylene diamine tetra-acetic acid(kEDTA) containing tubes.
These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt
- Drug Research Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is at least 18-55 years at screening.
- Subject has a Body Mass Index of 18 to 35 kg/m2.
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Metformin
Subjects administered Metformin 500mg(Glucophage tablets) twice daily till day(4) then Metformin 1000mg twice daily till day(7)
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Metformin is used primarly in treatment of diabetes type II
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EXPERIMENTAL: 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)
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Metformin is used primarly in treatment of diabetes type II
Daclatsvir is a direct acting antiviral drug
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(AUC0→12)
Time Frame: From first sampling interval(time zero) up to 12 hours
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Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml)
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From first sampling interval(time zero) up to 12 hours
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Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞)
Time Frame: From first sampling interval up to infinity
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Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml)
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From first sampling interval up to infinity
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Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau)
Time Frame: From first sampling interval up to dosing interval(Tau)
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Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml)
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From first sampling interval up to dosing interval(Tau)
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Maximum drug concentration in plasma at steady state(Cpss)
Time Frame: Time corresponding to maximum drug concentration in plasma at steady state
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Maximum drug concentration in plasma at steady state measured in (ng/ml)
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Time corresponding to maximum drug concentration in plasma at steady state
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Half life( t½) of drug in plasma
Time Frame: Up to 12 hours
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Half life of drug measured in Hours(hr)
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Up to 12 hours
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Mean residence time of drug(MRT)
Time Frame: From first sampling interval up to 12 hours
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Mean residence time of drug in plasma measured in (hr)
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From first sampling interval up to 12 hours
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steady state Clearance of drug(CLss)
Time Frame: From first sampling interval up to 12 hours
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steady state Clearance of drug measured in (ml/min)
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From first sampling interval up to 12 hours
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Renal Clearance of drug(CLr)
Time Frame: From first sampling interval up to 12 hours
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Renal Clearance of drug measured in (ml/min)
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From first sampling interval up to 12 hours
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Cumulative amount of drug eliminated in urine (Ae)
Time Frame: From first sampling interval up to 12 hours
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Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml)
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From first sampling interval up to 12 hours
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Maximum excretion rate (Urate max)
Time Frame: From first sampling interval up to 12 hours
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Maximum excretion rate for the drug measured in (milligram(mg)/hr)
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From first sampling interval up to 12 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Glucose(BG) levels
Time Frame: up to 3 hours
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Blood glucose levels measured in (mg/dl)
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up to 3 hours
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Area under the BG-time curve(AUG)0-3hr
Time Frame: up to 3 hours
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Area under the BG-time curve measured in (mg.hr/dl)
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up to 3 hours
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Maximum Glucose concentration(Gmax)
Time Frame: up to 3 hours
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Maximum Glucose concentration measured in (mg/dl)
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up to 3 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Raslan, Ainshams university
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Diabetes Mellitus, Type 2
- Hepatitis C
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Metformin
Other Study ID Numbers
- MET-DAC\DDIS\01217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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