NCT01546597

Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine

A Phase 1, Open-Label, Single Cohort, Four-period Sequential Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 on the steady state 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 on the steady state 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 at steady-state in subjects with T2DM. * To determine the steady-state PK of ranolazine in subjects with T2DM receiving metformin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Metformin	* Metformin 500 mg bid on Days 1-5 * Metformin 850 mg bid on Days 6-10 * Metformin 500 mg bid on Days 11-15 * Metformin 850 mg bid on Days 16-20
DRUG	Ranolazine	* Ranolazine 1000 mg bid on Days 11-15 * Ranolazine 1000 mg bid on Days 16-20

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