HealthyPhase 1DW6008NCT03127046
Drug-drug Interaction Between Aceclofenac 200 mg and Esomeprazole 20 mg in Healthy Male Volunteers
A Phase 1 study testing Aceclofenac, Esomeprazole and Aceclofenac and Esomeprazole in people with Healthy, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
To evaluate the drug-drug interaction between aceclofena and esomeprazole Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aceclofenac, Esomeprazole and Aceclofenac and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2017to 23 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital.
Jeonju, Jeollabuk-do, 561-712
About this study
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
To evaluate the drug-drug interaction between aceclofena and esomeprazole
Read the 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
- Being tested
- Aceclofenac, Esomeprazole, Aceclofenac and Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AceclofenacDrug
Also called Airtal tablet
Oral single dose administration of aceclofenac 200mg
EsomeprazoleDrug
Also called Nexium tablet
Oral single dose administration of aceclofenac 200mg
Aceclofenac and EsomeprazoleDrug
Also called Airtal and Nexium concomitant
Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole Receives: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac and Esomeprazole |
| Group 2 | Experimental | Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole Receives: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac and Esomeprazole |
| Group 3 | Experimental | Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac Receives: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac and Esomeprazole |
| Group 4 | Experimental | Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac Receives: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac and Esomeprazole |
| Group 5 | Experimental | Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole Receives: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac and Esomeprazole |
| Group 6 | Experimental | Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole Receives: Drug: Aceclofenac; Drug: Esomeprazole; Drug: Aceclofenac and Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration of aceclofenac and esomeprazole in plasma
Measured: up to 24hours
AUClast
Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma
Measured: up to 24hours
Secondary outcomes (4)
t1/2
Terminal half-time of aceclofenac and esomeprazole in plasma
Measured: up to 24hours
Tmax
Time to reach Cmax of aceclofenac and esomeprazole in plasma
Measured: up to 24hours
CL/F
Apparent clearance of aceclofenac and esomeprazole
Measured: up to 24hours
Vd/F
Apparent volume of distribution of aceclofenac and esomeprazole
Measured: up to 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start31 Mar 2017
- Primary completion16 Apr 2017
- Study completion23 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, PhD, Principal investigator, Chonbuk National University Hospital in Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127046
- Sponsor's protocol ID
- DW6008-I-1
- Acronym
- DW6008
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03127046
- Acronym / sponsor ID
- DW6008 / DW6008-I-1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 16 Apr 2017 (actual)
- Study completion
- 23 Apr 2017 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Aceclofenac, Drug: Esomeprazole, Drug: Aceclofenac and EsomeprazoleAceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole |
| Group 2 | Experimental | Drug: Aceclofenac, Drug: Esomeprazole, Drug: Aceclofenac and EsomeprazoleConcomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole |
| Group 3 | Experimental | Drug: Aceclofenac, Drug: Esomeprazole, Drug: Aceclofenac and EsomeprazoleEsomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac |
| Group 4 | Experimental | Drug: Aceclofenac, Drug: Esomeprazole, Drug: Aceclofenac and EsomeprazoleConcomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac |
| Group 5 | Experimental | Drug: Aceclofenac, Drug: Esomeprazole, Drug: Aceclofenac and EsomeprazoleEsomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole |
| Group 6 | Experimental | Drug: Aceclofenac, Drug: Esomeprazole, Drug: Aceclofenac and EsomeprazoleAceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AceclofenacAlso: Airtal tabletOral single dose administration of aceclofenac 200mg | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| EsomeprazoleAlso: Nexium tabletOral single dose administration of aceclofenac 200mg | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Aceclofenac and EsomeprazoleAlso: Airtal and Nexium concomitantOral single dose administration of aceclofenac 200mg and esomeprazole concomitant | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Cmax
Time frame: up to 24hours
Maximum concentration of aceclofenac and esomeprazole in plasma
AUClast
Time frame: up to 24hours
Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma
4 secondary outcomes
t1/2
Time frame: up to 24hours
Tmax
Time frame: up to 24hours
CL/F
Time frame: up to 24hours
Vd/F
Time frame: up to 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Gul Kim, PhD principal investigator
Chonbuk National University Hospital in Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aceclofenac, Esomeprazole and Aceclofenac and Esomeprazole in people with Healthy, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 24hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.