Evaluating the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112

Study Overview
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Brief Summary
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A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112

Detailed Description
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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

Official Title
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A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects

Conditions
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Pain

Intervention / Treatment
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* Drug: AD-2111
* Drug: AD-2112


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Adult aged 19 and more at the time of screening visit Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit Exclusion Criteria: As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg | Drug: AD-2111<br>* celecoxib 200mg<br>Drug: AD-2112<br>* Tramadol 150mg<br>|
| Experimental: Treatment B<br>Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg | Drug: AD-2111<br>* celecoxib 200mg<br>Drug: AD-2112<br>* Tramadol 150mg<br>|
| Experimental: Treatment C<br>Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg | Drug: AD-2111<br>* celecoxib 200mg<br>Drug: AD-2112<br>* Tramadol 150mg<br>|
| Experimental: Treatment D<br>Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg | Drug: AD-2111<br>* celecoxib 200mg<br>Drug: AD-2112<br>* Tramadol 150mg<br>|
| Experimental: Treatment E<br>Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg | Drug: AD-2111<br>* celecoxib 200mg<br>Drug: AD-2112<br>* Tramadol 150mg<br>|
| Active Comparator: Treatment F<br>Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg | Drug: AD-2111<br>* celecoxib 200mg<br>Drug: AD-2112<br>* Tramadol 150mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |