Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers

Study Overview
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Brief Summary
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To evaluate the drug-drug interaction between aceclofena and esomeprazole

Detailed Description
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A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drug interaction between Aceclofenac 200 mg and Esomeprazole 20 mg in healthy male volunteers

Official Title
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A Randomized, Open-label, Single Dose, 3-way Crossover Study to Evaluate the Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Aceclofenac
* Drug: Esomeprazole
* Drug: Aceclofenac and Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy man over 19 years old Body Mass Index(BMI)=17.5 30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2) Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings Depending on the nature of the drug your doctor check conducted hematology, blood chemistry, urinalysis and laboratory tests, including an electrocardiogram(EKG) performed during screening tests such as a suitable test subjects who judged The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the Institutional Review Board(IRB)-approved consent form signed by the parties in writing Exclusion Criteria: one with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence one with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 times the upper limit of the normal range Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g) Take part in other clinical trials within three months Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg The great history of alcohol or drug abuse within 1 year Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days More than 20 cigarettes a day smoker Taking medication of a prescription drug or nonprescription within 10 days, Within two months the whole blood donation have, within one month of the apheresis donation have Participate in clinical trials to test drug administration and may be at increased risk due to interpretation of test results, or may interfere with severe supply / chronic medical or mental condition or abnormal laboratory test values in character

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole | Drug: Aceclofenac<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Airtal tablet;Drug: Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Nexium tablet;Drug: Aceclofenac and Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant<br>* Other names: Airtal and Nexium concomitant;|
| Experimental: Group 2<br>Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole | Drug: Aceclofenac<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Airtal tablet;Drug: Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Nexium tablet;Drug: Aceclofenac and Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant<br>* Other names: Airtal and Nexium concomitant;|
| Experimental: Group 3<br>Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac | Drug: Aceclofenac<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Airtal tablet;Drug: Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Nexium tablet;Drug: Aceclofenac and Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant<br>* Other names: Airtal and Nexium concomitant;|
| Experimental: Group 4<br>Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac | Drug: Aceclofenac<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Airtal tablet;Drug: Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Nexium tablet;Drug: Aceclofenac and Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant<br>* Other names: Airtal and Nexium concomitant;|
| Experimental: Group 5<br>Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole | Drug: Aceclofenac<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Airtal tablet;Drug: Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Nexium tablet;Drug: Aceclofenac and Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant<br>* Other names: Airtal and Nexium concomitant;|
| Experimental: Group 6<br>Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole | Drug: Aceclofenac<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Airtal tablet;Drug: Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg<br>* Other names: Nexium tablet;Drug: Aceclofenac and Esomeprazole<br>* Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant<br>* Other names: Airtal and Nexium concomitant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration of aceclofenac and esomeprazole in plasma | up to 24hours | 
| AUClast | Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma | up to 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t1/2 | Terminal half-time of aceclofenac and esomeprazole in plasma | up to 24hours | 
| Tmax | Time to reach Cmax of aceclofenac and esomeprazole in plasma | up to 24hours | 
| CL/F | Apparent clearance of aceclofenac and esomeprazole | up to 24hours | 
| Vd/F | Apparent volume of distribution of aceclofenac and esomeprazole | up to 24hours |