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

April 23, 2017 updated by: Dong Wha Pharmaceutical Co. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 24hours
Maximum concentration of aceclofenac and esomeprazole in plasma
up to 24hours
AUClast
Time Frame: up to 24hours
Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma
up to 24hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
t1/2
Time Frame: up to 24hours
Terminal half-time of aceclofenac and esomeprazole in plasma
up to 24hours
Tmax
Time Frame: up to 24hours
Time to reach Cmax of aceclofenac and esomeprazole in plasma
up to 24hours
CL/F
Time Frame: up to 24hours
Apparent clearance of aceclofenac and esomeprazole
up to 24hours
Vd/F
Time Frame: up to 24hours
Apparent volume of distribution of aceclofenac and esomeprazole
up to 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dong Wha Pharmaceutical Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min-Gul Kim, PhD, Chonbuk National University Hospital in Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Aceclofenac

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings