Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
Tablets, Oral, 20 mg, Single Dose
Tablets, Oral, 20 mg, Single Dose
Oral, 40 mg, Single Dose
Mds Pharma Services (Us) Inc.
Neptune City, New Jersey, United States
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Time frame: 72 hours post-dose
To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects
Time frame: 15 timepoints
To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects
Time frame: 15 timepoints
To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects
Time frame: 15 timepoints
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Tablets, Oral, 320 mg, Single Dose