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

Healthy Clinical Trial

— DW6008  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03127046
• Other study ID #: DW6008-I-1
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: April 10, 2017
• Last updated: April 23, 2017
• Start date: March 31, 2017
• Est. completion date: April 23, 2017

Study information

• Verified date: April 2017
• Source: Dong Wha Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the drug-drug interaction between aceclofena and esomeprazole

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: April 23, 2017
• Est. primary completion date: April 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Aceclofenac
Oral single dose administration of aceclofenac 200mg
• Esomeprazole
Oral single dose administration of aceclofenac 200mg
• Aceclofenac and Esomeprazole
Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital.	Jeonju-si	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Dong Wha Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum concentration of aceclofenac and esomeprazole in plasma	up to 24hours
Primary	AUClast	Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma	up to 24hours
Secondary	t1/2	Terminal half-time of aceclofenac and esomeprazole in plasma	up to 24hours
Secondary	Tmax	Time to reach Cmax of aceclofenac and esomeprazole in plasma	up to 24hours
Secondary	CL/F	Apparent clearance of aceclofenac and esomeprazole	up to 24hours
Secondary	Vd/F	Apparent volume of distribution of aceclofenac and esomeprazole	up to 24hours