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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort B | Other | Experimental : GB-6002 for subcutaneous injection at intermediate A dose. Placebo Comparator: Placebo for subcutaneous injection at intermediate intermediate A dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose. |
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| Cohort C | Other | Experimental : GB-6002 for subcutaneous injection at intermediate B dose. Placebo Comparator: Placebo for subcutaneous injection at intermediate B dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose. |
|
| Cohort D | Other | Experimental : GB-6002 for subcutaneous injection at high dose. Placebo Comparator: Placebo for subcutaneous injection at high dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose. |
|
| Cohort A | Other | Experimental : GB-6002 for subcutaneous injection at low dose. Placebo Comparator: Placebo for subcutaneous injection at low dose. Active Comparator: Naropin injection(Ropivacaine hydrochloride), single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB-6002 | Drug | Depending on the cohort, volume will be varied to administer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1 to Day 14 |
| Physical examination | Incidence of abnormal clinically significant Physical examination results by Study arm. | 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. | Day 1 to Day 14 |
| Electrocardiograms | Incidence of abnormal clinically significant ECG results by Study arm. | Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(Cmax) | Day 1 to Day 14 | |
| Pharmacokinetics(AUCt) | Day 1 to Day 14 | |
| Pharmacokinetics(AUCinf) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Yoon | Republic of Korea, Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
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| Placebo | Drug | Depending on the cohort, volume will be varied to administer. Volume to be matched with the active investigational drug in the respective cohort. |
|
| Naropin injection | Drug | Single dose of Naropin s.c. injection. |
|
| Day 1 to Day 14 |
| Pharmacokinetics(Tmax) | Day 1 to Day 14 |
| Pharmacokinetics(t1/2) | Day 1 to Day 14 |
| Pharmacokinetics(CL/F) | Day 1 to Day 14 |
| Pharmacokinetics(Vz/F) | Day 1 to Day 14 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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