Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Yonsei University Severance Hospital
Soeul, South Korea
RECRUITINGCmax of Dapagliflozin
Maximum plasma concentration of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Cmax of Metformin
Maximum plasma concentration of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUClast of Dapagliflozin
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUClast of Metformin
Area under the plasma concentration-time curve to last concentration of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUCinf of Dapagliflozin
Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUCinf of Metformin
Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Dapagliflozin
Time to maximum plasma concentration of Dapagliflozin
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Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Metformin
Time to maximum plasma concentration of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Dapagliflozin
Half-life of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Metformin
Half-life of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Dapagliflozin
Apparent volume of distribution of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Metformin
Apparent volume of distribution of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Dapagliflozin
Apparent clearance of Dapagliflozin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Metformin
Apparent clearance of Metformin
Time frame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration