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

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

To evaluate the drug-drug interaction between aceclofena and esomeprazole

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
      • Chonbuk National University Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Min-Gul Kim, PhD, Chonbuk National University Hospital in Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): April 16, 2017
• Study Completion (Anticipated): April 23, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 23, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 23, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Diclofenac; Esomeprazole; Aceclofenac
• Other Study ID Numbers: DW6008-I-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes