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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03686722
Other study ID # MET-DAC\DDIS\01217
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 9, 2017
Est. completion date December 6, 2017

Study information

Verified date October 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 6, 2017
Est. primary completion date October 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

1. Subject is at least 18-55 years at screening.

2. Subject has a Body Mass Index of 18 to 35 kg/m2.

3. Subject are non smokers or moderate smokers(not more than 10 cigarettes per day)

4. Subjects is willing to participate and give their final written consent prior to the commencement of the study procedures

5. 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.

6. Subject has a normal blood pressure and pulse rate, according to the reference normal ranges.

Exclusion Criteria:

1. Treatment with any known enzyme-inducing/inhibiting agents prior to the start of the study and throughout the study.

2. Subjects who have taken any medication two weeks preceding of the trial starting date.

3. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.

4. Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.

5. Gastrointestinal diseases.

6. Renal diseases.

7. Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .

8. Pancreatic disease including diabetes.

9. Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases

10. Hematological disease or pulmonary disease

11. Abnormal laboratory values.

12. Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.

13. Positive HIV test.

14. History of or current abuse of drugs, alcohol or solvents.

15. Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extrahepatic tumors

16. Autoimmune disorders as Graves disease

17. Central nervous system (CNS) disorders

Study Design


Intervention

Drug:
Metformin
Metformin is used primarly in treatment of diabetes type II
Daclatasvir
Daclatsvir is a direct acting antiviral drug

Locations

Country Name City State
Egypt Drug research centre Cairo

Sponsors (3)

Lead Sponsor Collaborator
Mohamed Raslan Ain Shams University, Drug Research Centre, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
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
Primary Area under the plasma concentration-time curve from time 0 to infinity (AUC0?8) Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml) From first sampling interval up to infinity
Primary 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)
Primary 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
Primary Half life( t½) of drug in plasma Half life of drug measured in Hours(hr) Up to 12 hours
Primary Mean residence time of drug(MRT) Mean residence time of drug in plasma measured in (hr) From first sampling interval up to 12 hours
Primary steady state Clearance of drug(CLss) steady state Clearance of drug measured in (ml/min) From first sampling interval up to 12 hours
Primary Renal Clearance of drug(CLr) Renal Clearance of drug measured in (ml/min) From first sampling interval up to 12 hours
Primary 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
Primary 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
Secondary Area under the BG-time curve(AUG)0-3hr Area under the BG-time curve measured in (mg.hr/dl) up to 3 hours
Secondary Maximum Glucose concentration(Gmax) Maximum Glucose concentration measured in (mg/dl) up to 3 hours
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