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

NCT ID: NCT03127046

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2017-04-23

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Aceclofenac and Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Group 2

Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Aceclofenac and Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Group 3

Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Aceclofenac and Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Group 4

Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Aceclofenac and Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Group 5

Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Aceclofenac and Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Group 6

Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole

Group Type: EXPERIMENTAL

Aceclofenac

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg

Aceclofenac and Esomeprazole

Intervention Type: DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Interventions

Aceclofenac

Oral single dose administration of aceclofenac 200mg

Intervention Type: DRUG

Esomeprazole

Oral single dose administration of aceclofenac 200mg

Intervention Type: DRUG

Aceclofenac and Esomeprazole

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Intervention Type: DRUG

Other Intervention Names

Airtal tablet; Nexium tablet; Airtal and Nexium concomitant

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dong Wha Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-Gul Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital in Korea

Locations

Chonbuk National University Hospital.

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

DW6008-I-1

Identifier Type: -

Identifier Source: org_study_id