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Gastroesophageal Reflux DiseasePhase 1NCT04703868

A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

A Phase 1 study testing Rabeprazole Sodium 10mg and Rabeprazole Sodium 20mg in people with Gastroesophageal Reflux Disease, run by Yungjin Pharm. Co., Ltd. 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

A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
Rabeprazole Sodium 10mg and Rabeprazole Sodium 20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteSouth Korea
Study dates
13 Jan 2021to 14 Jun 2021
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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 19~55 years in healthy volunteers
  • BMI is more than 18.0 kg/m^2 , no more than 28.0 kg/m^2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Who cannot join

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who were judged ineligible by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, Daehak-ro Jongno-gu, 110-744

Other trials in South Korea

About this study

A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Read the detailed description

This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Being tested
Rabeprazole Sodium 10mg, Rabeprazole Sodium 20mg
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • Rabeprazole Sodium 10mgDrug

    Also called Reference drug

    Part A: 1 tablet administered before the breakfast during 7 days

  • Rabeprazole Sodium 20mgDrug

    Also called Reference drug

    Part B: 1 tablet administered before the breakfast during 7 days

Study groups in NCT04703868
Study groupRoleWhat they receive
YPI-011 10/500mgExperimentalPart A: 1 tablet administered before the breakfast during 7 days
Receives: Drug: Rabeprazole Sodium 10mg
YPI-011 20/500mgExperimentalPart B: 1 tablet administered before the breakfast during 7 days
Receives: Drug: Rabeprazole Sodium 20mg

What is being measured

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

  1. Integrated gastric acidity

    Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose

    Measured: From Day 1 up to Day 28

  2. AUCt,ss

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

Secondary outcomes (16)

  1. Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose

    Evaluateion PD Rabeprazole after multiple dose

    Measured: 24 hours

  2. Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose

    Evaluateion PD Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 28

  3. Mean and median gastric pH after 1st and 7th dose

    Evaluateion PD Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 28

  4. AUCτ

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  5. Cmax

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  6. Tmax

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  7. t1/2

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  8. CL/F

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  9. Vz/F

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  10. Cmin,ss,

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  11. Cmax,ss

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  12. Cav,ss,

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  13. Tmax,ss

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  14. t1/2,ss

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  15. CLss/F

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

  16. Vss/F

    Evaluateion PK Rabeprazole after multiple dose

    Measured: From Day 1 up to Day 29

Timeline

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

  1. First posted11 Jan 2021
  2. Study start13 Jan 2021
  3. Primary completion1 Jun 2021
  4. Study completion14 Jun 2021

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04703868
Sponsor's protocol ID
YJ26-101
Status last verified
Jan 2024
First submitted
7 Jan 2021
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rabeprazole Sodium 10mg and Rabeprazole Sodium 20mg in people with Gastroesophageal Reflux Disease, run by Yungjin Pharm. 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 3 inclusion and 2 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 24 Jan 2024. 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?

Integrated gastric acidity (time frame: From Day 1 up to Day 28). 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 NCT04703868.

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 24 Jan 2024.

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