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HealthyPhase 1YH4808-108NCT01921647

The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

A Phase 1 study testing YH4808, Nexium and Amoxicillin 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 not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy… Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
YH4808, Nexium and Amoxicillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteSouth Korea
Study dates
Jul 2013to Nov 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
  • Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  • Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead GCG etc)

Who cannot join

  • Subject who is hypersensitive to components contained in YH4808 or this drug
  • Subject 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 has history of surgical operation or diseases related to gastrointestinal symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
  • Other exclusions apply

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers

Conditions
Healthy
Being tested
YH4808, Nexium, Amoxicillin, clarithromycin
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

    Also called experimental drug

  • NexiumDrug

    Also called active comparator

  • AmoxicillinDrug

    Also called experimental drug

  • clarithromycinDrug

    Also called experimental drug

Study groups in NCT01921647
Study groupRoleWhat they receive
YH4808, amoxicillin, clarithromycinExperimentalsingle administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
Receives: Drug: YH4808; Drug: Amoxicillin; Drug: clarithromycin
YH4808, amoxicillin and clarithromycinExperimental7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
Receives: Drug: YH4808; Drug: Amoxicillin; Drug: clarithromycin
YH4808 and amoxicillinExperimental7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication
Receives: Drug: YH4808; Drug: Amoxicillin
nexium, amoxicillin and clarithromycinActive comparatorBID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
Receives: Drug: Nexium; Drug: Amoxicillin; Drug: clarithromycin

What is being measured

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

  1. Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

    Measured: pre dose, 16 times after dosing

Secondary outcomes (1)

  1. Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

    Measured: pre dose, 16 times after dosing

Timeline

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

  1. First posted13 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionNov 2013
  4. Study completionNov 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
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01921647
Sponsor's protocol ID
YH4808-108
Acronym
YH4808-108
Status last verified
Dec 2013
First submitted
8 Aug 2013
Last updated
3 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • Park H, Kim CO, Kim M, Lim Y, Lee WY, Yoon S, Park MS. Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):136-146. doi: 10.12793/tcp.2020.28.e16. Epub 2020 Sep 23.

    PubMed 33062627

  • Lee WY, Oh E, Cui M, Kim CO, Lim Y, Kim H, Park H, Yoon S, Park MS, Hong T. Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects. Transl Clin Pharmacol. 2020 Mar;28(1):55-65. doi: 10.12793/tcp.2020.28.e5. Epub 2020 Mar 31.

    PubMed 32274381

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YH4808, Nexium and Amoxicillin 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 3 inclusion and 4 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 3 Dec 2013. 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, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin (time frame: pre dose, 16 times after dosing). 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 NCT01921647, which also lists 2 linked publications.

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 3 Dec 2013.

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