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HealthyPhase 1NCT01876615

Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac

A Phase 1 study testing YH4808, Diclofenac and YH4808+Diclofenac in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to compare pharmacokinetics after single oral administration of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in healthy male volunteers Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
YH4808, Diclofenac and YH4808+Diclofenac
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteSouth Korea
Study dates
Jul 2013to Dec 2013
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 20 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy male age 20 to 45 over 55kg with Ideal body weight(IBW)
  • No clinically important abnormal physical findings at the screening examination
  • Subject who has no congential, chronic disease and disease symptoms in medical examination result
  • Subject who is judged to be eligible by principal inverstigator or sub-investigator according to various reasons includiong ther abnorminal test results(clinical laboratory test, 12-lead GCG etc)
  • Ability to communicate well with the inverstigator and to comply with the requremetns of the entire study
  • Willingness to give written informed consent(prior to any study-related procedures beinging performed) and to be able to adhere to the study restrictions and examination schedule

Who cannot join

  • Suject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
  • Subject who is hypersensitive to components contained in YH4808 or declofenac or related drug(ex. rebamipide, revaprazan, NSID etc)
  • Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
  • Subject who has history of drug dependence or using that drug
  • Subject who had taken usual dose of any prescription durgs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment
  • Subject who participated in antoher clinical trial within 2 monthes before enrolling in this study
Show all 10Show fewer
  • subject who donated whole blood within 2 months or component blood within 1 month before the treatment
  • Subject who drank over 21unit/week(1 unit= 10g of alcohol) or were not able to refrain from drinking alcohol during study days
  • Subject who stopped smoking within 3 months before the treatment or detected cotinine in urine test
  • Subject with clinically significant observations considered as unsuitable based on medical judgment by the investigators

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungnam National University Hospital

    Daejeon

Other trials in South Korea

About this study

Official title: A Randomized, Open-Label, Single-dosing and Cross-over Clinical Trial to Investigate the Safety and Pharmacokinetic Drug-Drug Interaction of YH4808 and Diclofenac in Healthy Male Volunteers

The objective of this study is to compare pharmacokinetics after single oral administration of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in healthy male volunteers

Conditions
Healthy
Being tested
YH4808, Diclofenac, YH4808+Diclofenac
Keywords
safety/tolerability and pharmacokinetics/pharmacodynamics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YH4808Drug

    experimental drug

  • DiclofenacDrug

    Also called Depain tablet 25mg

    Depain tablet 25mg

  • YH4808+DiclofenacDrug

Study groups in NCT01876615
Study groupRoleWhat they receive
YH4808 or Diclofenac or YH4808+Diclofenac(arm 1)Experimental6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Receives: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac
YH4808 or Diclofenac or YH4808+Diclofenac (arm 2)Experimental6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Receives: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac
YH4808 or Diclofenac or YH4808+Diclofenac (arm 3)Experimental6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Receives: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac
YH4808 or Diclofenac or YH4808+Diclofenac (arm 4)Experimental6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Receives: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac
YH4808 or Diclofenac or YH4808+Diclofenac (arm5)Experimental6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Receives: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac
YH4808 or Diclofenac or YH4808+Diclofenac (arm6)Experimental6 arm, 3 Sequence design * YH4808 or Diclofenac or YH4808+Diclofenac * 3 week wash out period is between each period.
Receives: Drug: YH4808; Drug: Diclofenac; Drug: YH4808+Diclofenac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of YH4808

    Measured: 18 points up to Day 2 or Day 3

  2. AUClast of YH4808

    Measured: 18 points up to Day 3

Secondary outcomes (7)

  1. AUCinf of YH4808

    Measured: 18 points up to Day 3

  2. AUCinf of Diclofenac

    Measured: 16points up to Day 2

  3. t1/2 of YH4808

    Measured: 18 points up to Day 3

  4. t1/2 of Diclofenac

    Measured: 16 points up to Day 2

  5. Tmax of YH4808

    Measured: 18 points up to Day 3

  6. Tmax of Diclofenac

    Measured: 16 points up to Day 2

  7. Metabolic ratio

    Measured: 18 points up to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01876615
Sponsor's protocol ID
YH4808-109
Status last verified
Dec 2013
First submitted
10 Jun 2013
Last updated
1 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YH4808, Diclofenac and YH4808+Diclofenac in people with Healthy, run by Yuhan Corporation 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 1 Jan 2014. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of YH4808 (time frame: 18 points up to Day 2 or Day 3). 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?

On the ClinicalTrials.gov record for NCT01876615.

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 1 Jan 2014.

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