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

NCT03127046 | Unknown Phase 1 FDA Drug

• 1 other identifier: DW6008-I-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the drug-drug interaction between aceclofena and esomeprazole

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• t1/2

  up to 24hours

• Tmax

  up to 24hours

• CL/F

  up to 24hours

• Vd/F

  up to 24hours

Study Arms (6)

Group 1

EXPERIMENTAL

Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole

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

Group 2

EXPERIMENTAL

Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole

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

Group 3

EXPERIMENTAL

Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac

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

Group 4

EXPERIMENTAL

Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac

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

Group 5

EXPERIMENTAL

Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole

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

Group 6

EXPERIMENTAL

Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole

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

Interventions

Aceclofenac DRUG

Oral single dose administration of aceclofenac 200mg

Also known as: Airtal tablet

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Esomeprazole DRUG

Oral single dose administration of aceclofenac 200mg

Also known as: Nexium tablet

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Aceclofenac and Esomeprazole DRUG

Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Also known as: Airtal and Nexium concomitant

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Chonbuk National University Hospital.

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

MeSH Terms

Interventions

aceclofenac; Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Min-Gul Kim, PhD

  Chonbuk National University Hospital in Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 25, 2017
• Study Start: March 31, 2017
• Primary Completion: April 16, 2017
• Study Completion: April 23, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)