Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers (DW6008)

Dong Wha Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Aceclofenac and Esomeprazole; Drug: Aceclofenac; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03127046

DW6008-I-1

Details and patient eligibility

About

To evaluate the drug-drug interaction between aceclofena and esomeprazole

Full 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

Enrollment: 30 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Group 1

Experimental group

Description:

Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole

Treatment:

Drug: Esomeprazole

Drug: Aceclofenac

Drug: Aceclofenac and Esomeprazole

Group 2

Experimental group

Description:

Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole

Treatment:

Drug: Esomeprazole

Drug: Aceclofenac

Drug: Aceclofenac and Esomeprazole

Group 3

Experimental group

Description:

Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac

Treatment:

Drug: Esomeprazole

Drug: Aceclofenac

Drug: Aceclofenac and Esomeprazole

Group 4

Experimental group

Description:

Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac

Treatment:

Drug: Esomeprazole

Drug: Aceclofenac

Drug: Aceclofenac and Esomeprazole

Group 5

Experimental group

Description:

Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole

Treatment:

Drug: Esomeprazole

Drug: Aceclofenac

Drug: Aceclofenac and Esomeprazole

Group 6

Experimental group

Description:

Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole

Treatment:

Drug: Esomeprazole

Drug: Aceclofenac

Drug: Aceclofenac and Esomeprazole