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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg |
|
| Treatment B | Experimental | Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg |
|
| Treatment C | Experimental | Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg |
|
| Treatment D | Experimental | Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg |
|
| Treatment E | Experimental | Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg |
|
| Treatment F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-2111 | Drug | celecoxib 200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve in time plot (AUCt) | AUCt of the total ingredient of Celecoxib, Tramadol | pre-dose to 72 hours |
| Peak Plasma Concentration (Cmax) | Cmax of the total ingredient of Celecoxib, Tramadol | pre-dose to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve in time plot (AUCinf) | AUCinf of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol | pre-dose to 72 hours |
| Time to reach Cmax(Tmax) | Tmax of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, M.D., Ph.D | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg |
|
| AD-2112 | Drug | Tramadol 150mg |
|
| pre-dose to 72 hours |
| Effective half-life(t1/2) | t1/2 of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol | pre-dose to 72 hours |
| Clearance(CL/F) | CL/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol | pre-dose to 72 hours |
| Volume of distribution(Vd/F) | Vd/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol | pre-dose to 72 hours |
| Area under the curve in time plot (AUCt) of O-desmethyltramadol | AUCt of the total ingredient of O-desmethyltramadol | pre-dose to 72 hours |
| Peak Plasma Concentration (Cmax) of O-desmethyltramadol | Cmax of the total ingredient of O-desmethyltramadol | pre-dose to 72 hours |