A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Volunteers
Part 1: to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Koreans/ Part 2: to evaluate the safety, PK/PD of Epaminurad in Healthy Caucasians
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Period 1: Epaminurad 6mg -\> Epaminurad 9mg -\> Epaminurad 9mg +Naproxen Period 2: Naproxen
Epaminurad
Epaminurad placebo
Seoul National University Hospital
Seoul, South Korea
Area under the plasma concentration versus time curve (AUC)
To evaluate the AUC of Naproxen
Time frame: 5 days
Area under the plasma concentration versus time curve (AUC)
To evaluate the AUC of Epaminurad
Time frame: 7 days
Peak plasma concentrations (Cmax)
To evaluate the Cmax of Epaminurad
Time frame: 7 days
Peak plasma concentrations (Cmax)
To evaluate the Cmax of Naproxen
Time frame: 5 days
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