Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg
| Status: | Archived |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2012 |
| End Date: | April 2012 |
| Contact: | Nicola Pannacciulli, MD, PhD |
| Email: | Nico.Pannacciulli@gilead.com |
| Phone: | (650) 522-5833 |
A Phase 1, Open-label, Single Cohort, Two-Period Fixed Sequence Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg Twice Daily in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on
the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes
mellitus (T2DM).
The primary objective of this study is as follows:
• To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady
state pharmacokinetics (PK) of metformin in subjects with T2DM.
The secondary objectives of this study are as follows:
- To examine the safety and tolerability of metformin when co administered with
ranolazine 500 mg bid at steady-state in subjects with T2DM.
- To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM
receiving metformin.
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