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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
25
Metformin 1000 mg bid on Days 1-10
Ranolazine 500 mg bid on Days 6-10
SeaView Research Inc.
Miami, Florida, United States
Maximum observed plasma concentration (Cmax) of metformin
Time frame: 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10
Area under the plasma concentration vs time curve over the dosing interval, at steady state (AUCtau) of metformin
Time frame: 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10
Number of participants with adverse events
Time frame: From time of signed informed consent to time of follow-up phone call, an expected average of 5 weeks
Maximum observed plasma concentration (Cmax) of ranolazine and metabolites
Time frame: 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10
Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites
Time frame: 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10
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