The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
Seoul National University Hospital
Seoul, South Korea
Peak Plasma Concentration
Cmax of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Area under the plasma concentration versus time curve
AUCtau of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Time to reach Cmax
Tmax of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Concentration
Ctrough of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Elimination half-life
t1/2 of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Clearance
CL/F of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Volume of distribution
Vd/F of the total ingredient of AD-2011 and AD-2012
Time frame: pre-dose to 24 hours
Number of participants with adverse events
Incidence rate of adverse events
Time frame: From Day 1 up to Day 45
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