This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.
This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers. Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14 days (13 subjects each). \[Group A\] Tramadol +Polmacoxib capsule \[Group B\] Polmacoxib capsule \[Group C\] Tramadol Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline; Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Seoul National University Hospital
Seoul, South Korea
AUCtau of Polmacoxib and Tramadol
Time frame: up to 4 weeks
Cmax of Polmacoxib and Tramadol
Time frame: up to 4 weeks
Cmax of Polmacoxib
Time frame: up to 4 weeks
AUC tau of Polmacoxib
Time frame: up to 4 weeks
Cmax of Tramadol
Time frame: up to 4 weeks
AUCtau of Tramadol
Time frame: up to 4 weeks
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