drugset / Trial / NCT02291510
Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects
RandomizedCrossoverSingle-blindBasic science
Summary
This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR, ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.
Timeline
- Start
- 2012-10
- Primary completion
- 2012-12
- Completion
- 2012-12
Publications
- Background DeFronzo RA, Buse JB, Kim T, Skare S, Baron A, Fineman M, editors. Dissociation between Metformin Plasma Exposure and its Glucose-Lowering Effect: A Novel Gut-Mediated Mechanism of Action. 73rd Annual Scientific Meeting of The American Diabetes Association; 2013 June 21-25th; Chicago, Il.
- Background Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 500 mg | — |
| Comparator | Metformin | Small molecule | 1000 mg | — |
| Comparator | Metformin | Small molecule | 2000 mg | — |
Indications
No indication recorded.