NCT01546558

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Metformin	Metformin 1000 mg bid on Days 1-10
DRUG	Ranolazine	Ranolazine 500 mg bid on Days 6-10

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-03-07
• Last updated: 2012-07-11

Locations

1 site across 1 country: United States