Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy male volunteer.
A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy male volunteer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
12
Linagliptin 5mg once daily for 7 days
Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days
Chonbuk National University Hospital
Jeonju, Jeollabukdo, South Korea
Cmax and AUC
Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)
Time frame: 1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour
Pharmacokinetic Profile of Plasma
Maximum drug concentration time(Tmax), Half-time(t1/2), Apparent renal clearance(CL/F), Apparent volume of distribution(Vd/F), Fluctuation\[(Css,max-Css,min)/Css,av\], Swing\[(Css,max-Css,min)/Css,min\]
Time frame: 1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour
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