To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults
This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51. This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together
Jang Hee Hong
Daejeon, Korea, South Korea
AUCt(Area Under Curve last) of AJU-A51
Area under the plasma concentration time curve of AJU-A51
Time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Cmax
The maximum concentration observed of AJU-A51 over blood sampling time.
Time frame: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
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