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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mohamed Raslan · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

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.

Conditions

• Diabetes Mellitus, Type 2
• Hepatitis C
• Drug Interactions

Interventions

Type	Name	Description
DRUG	Metformin	Metformin is used primarly in treatment of diabetes type II
DRUG	Daclatasvir	Daclatsvir is a direct acting antiviral drug

Timeline

• Start date: 2017-09-09
• Primary completion: 2017-10-30
• Completion: 2017-12-06
• First posted: 2018-09-27
• Last updated: 2018-10-12

Locations

1 site across 1 country: Egypt