This study is to evaluate the safety and tolerability of single dose of GB-6002 (Ropivacaine) Local Infiltration in healthy male Adults. And, It is to compare pharmacokinetic characteristics of GB-6002 single dose injection with active comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Adverse Events
Number of subjects and Incidences with adverse events by Study arm. Number of subjects and Incidences with Injection site assessments for nodules by Study arm.
Time frame: Day 1 to Day 14
Clinical Laboratory tests
Incidence of abnormal clinically significant clinical laboratory test results (Hematology, Blood Chemistry Test, Urine Test, Blood Coagulation Test, Serum Test and Urine Drug Screening Test, etc) by study arm.
Time frame: Day 1 to Day 14
Physical examination
Incidence of abnormal clinically significant Physical examination results by Study arm.
Time frame: Day 1 to Day 14
Vital signs
Incidence of abnormal clinically significant vital signs(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature) results by Study arm.
Time frame: Day 1 to Day 14
Electrocardiograms
Incidence of abnormal clinically significant ECG results by Study arm.
Time frame: Day 1 to Day 14
Pharmacokinetics(Cmax)
Time frame: Day 1 to Day 14
Pharmacokinetics(AUCt)
Time frame: Day 1 to Day 14
Pharmacokinetics(AUCinf)
Time frame: Day 1 to Day 14
Pharmacokinetics(Tmax)
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Time frame: Day 1 to Day 14
Pharmacokinetics(t1/2)
Time frame: Day 1 to Day 14
Pharmacokinetics(CL/F)
Time frame: Day 1 to Day 14
Pharmacokinetics(Vz/F)
Time frame: Day 1 to Day 14