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Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin

NCT03686722 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-10-12

No results posted yet for this study

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)

Conditions

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

Interventions

DRUG

Metformin

Metformin is used primarly in treatment of diabetes type II

DRUG

Daclatasvir

Daclatsvir is a direct acting antiviral drug

Sponsors & Collaborators

  • Ain Shams University

    collaborator OTHER

  • Drug Research Centre, Cairo, Egypt

    collaborator OTHER

  • Mohamed Raslan

    lead OTHER

Principal Investigators

  • Mohamed Raslan · Ainshams university

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-09
Primary Completion
2017-10-30
Completion
2017-12-06

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03686722 on ClinicalTrials.gov