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

• Status: Completed
• Trial end date: 2017-12-06
• Target enrollment: 0
• Participant gender: Male

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mohamed Raslan
• Collaborators: Ain Shams University; Drug Research Centre, Cairo, Egypt
• Treatments: Metformin

Criteria

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