Type 2 Diabetes Mellitus Clinical Trial
Official title:
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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