Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers
Phase 1
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT03127046
- Lead Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Brief Summary
To evaluate the drug-drug interaction between aceclofena and esomeprazole
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 3 Aceclofenac and Esomeprazole Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac Group 1 Aceclofenac Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole Group 1 Aceclofenac and Esomeprazole Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole Group 3 Aceclofenac Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac Group 4 Aceclofenac Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac Group 5 Aceclofenac and Esomeprazole Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole Group 4 Aceclofenac and Esomeprazole Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac Group 6 Esomeprazole Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole Group 6 Aceclofenac and Esomeprazole Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole Group 2 Aceclofenac and Esomeprazole Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole Group 1 Esomeprazole Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole Group 2 Aceclofenac Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole Group 2 Esomeprazole Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole Group 3 Esomeprazole Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac Group 4 Esomeprazole Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac Group 5 Aceclofenac Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole Group 5 Esomeprazole Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole Group 6 Aceclofenac Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole
- Primary Outcome Measures
Name Time Method AUClast up to 24hours Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma
Cmax up to 24hours Maximum concentration of aceclofenac and esomeprazole in plasma
- Secondary Outcome Measures
Name Time Method CL/F up to 24hours Apparent clearance of aceclofenac and esomeprazole
t1/2 up to 24hours Terminal half-time of aceclofenac and esomeprazole in plasma
Vd/F up to 24hours Apparent volume of distribution of aceclofenac and esomeprazole
Tmax up to 24hours Time to reach Cmax of aceclofenac and esomeprazole in plasma
Trial Locations
- Locations (1)
Chonbuk National University Hospital.
🇰🇷Jeonju-si, Jeollabuk-do, Korea, Republic of