drugset / Trial / NCT03686722
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
Phase 1
Completed
20 enrolled
Mohamed Raslan
Ain Shams University · collabDrug Research Centre, Cairo, Egypt · collab
RandomizedCrossoverDouble-blindOther
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)
Timeline
- Start
- 2017-09-09
- Primary completion
- 2017-10-30
- Completion
- 2017-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclatasvir | Small molecule | 60 mg | — |
| Subject | Metformin | Small molecule | 1000 mg | — |