A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112
Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Kyungpook National University Hospital
Daegu, South Korea
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of Celecoxib, Tramadol
Time frame: pre-dose to 72 hours
Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of Celecoxib, Tramadol
Time frame: pre-dose to 72 hours
Area under the curve in time plot (AUCinf)
AUCinf of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Time frame: pre-dose to 72 hours
Time to reach Cmax(Tmax)
Tmax of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Time frame: pre-dose to 72 hours
Effective half-life(t1/2)
t1/2 of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Time frame: pre-dose to 72 hours
Clearance(CL/F)
CL/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Time frame: pre-dose to 72 hours
Volume of distribution(Vd/F)
Vd/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Time frame: pre-dose to 72 hours
Area under the curve in time plot (AUCt) of O-desmethyltramadol
AUCt of the total ingredient of O-desmethyltramadol
Time frame: pre-dose to 72 hours
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Peak Plasma Concentration (Cmax) of O-desmethyltramadol
Cmax of the total ingredient of O-desmethyltramadol
Time frame: pre-dose to 72 hours