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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
24
* 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
* Ranolazine 1000 mg bid on Days 11-15 * Ranolazine 1000 mg bid on Days 16-20
Cetero Research
San Antonio, Texas, 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, 10, 15 and 20
Time to reach 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, 10, 15 and 20
Area under the plasma concentration versus 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, 10, 15 and 20
Number of participants with adverse events
Time frame: participants will be followed upon signing informed consent until the follow-up phone call, an expected average of 7 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 Days 15 and 20
Time to reach 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 Days 15 and 20
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 Days 15 and 20
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