Clinical trial NCT03127046: Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Cmax
timeFrame: up to 24hours
measure: AUClast
timeFrame: up to 24hours
Secondary outcomes:
measure: t1/2
timeFrame: up to 24hours
measure: Tmax
timeFrame: up to 24hours
measure: CL/F
timeFrame: up to 24hours
measure: Vd/F
timeFrame: up to 24hours
Other outcomes:
Locations:
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital.
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital in Korea
name: Min-Gul Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: