Trials / Completed
CompletedNCT01658514
Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction
A Randomized, Crossover Study Assessing the Single Dose Pharmacokinetics of Delayed-Release Metformin in Subjects With Renal Dysfunction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Elcelyx Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Met DR | metformin delayed-release tablets |
| DRUG | Met XR | metformin extended-release tablets |
| DRUG | Placebo |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2012-08-07
- Last updated
- 2015-12-30
- Results posted
- 2015-12-30
Source: ClinicalTrials.gov record NCT01658514. Inclusion in this directory is not an endorsement.