To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Dapagliflozin 10mg + Linagliptin 5mg
Metformin 1000mg
Fixed-dose combination tablet (AJU-A53)
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea
Cmax of Dapagliflozin
To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
AUCt of Dapagliflozin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin
Time frame: 0 hour ~ 48 hour after drug administration
Cmax of Linagliptin
To assess the maximum observed plasma concentration (Cmax) of Linagliptin
Time frame: 0 hour ~ 72 hour after drug administration
AUCt of Linagliptin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin
Time frame: 0 hour ~ 72 hour after drug administration
Cmax of Metformin
To assess the maximum observed plasma concentration (Cmax) of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
AUCt of Metformin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
Time frame: 0 hour ~ 48 hour after drug administration
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