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Status unknownNCT04587011Updated Dec 28, 2020

A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects

A Phase 1 interventional study of Tegoprazan dose A or placebo and Tegoprazan dose B or placebo in Healthy, sponsored by HK inno.N Corporation. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-28.

Sponsored by HK inno.N Corporation · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.

Read the detailed description
  • To explore the pharmacokinetics, pharmacodynamics and safety in accordance with the dose escalation when tegoprazan is given orally twice daily for 3 days in healthy subjects.
  • To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects aged 19 to 45(inclusive) years at screening.
  • Subjects with body mass index (BMI) in the range of 18.5 kg/m\^2 to 28.0 kg/m\^2(inclusive)
  • Subjects who voluntarily agreed to participate in the study after being fully informed of the purpose, content, and characteristics of the investigational product(IP) prior to the study participation.

Exclusion criteria

Exclusion Criteria:

  1. Past medical history

    • Subjects who are determined by the investigator to have clinically significant history or disease related to the liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, urinary system and cardiovascular system including cardiac arrhythmia.
    • Subjects who are determined by the investigator to have past history of gastrointestinal diseases (ex.: gastritis, GERD, Crohn's disease, ulcers etc.) or abdominal surgery (except simple appendectomy or herniotomy) that may affect the IP absorption.
  2. Diagnostic test and electrocardiogram (ECG)

    • If H. pylori test result is positive at screening
    • If the AST or ALT value is more than 1.25 times the upper limit of normal under the screening test
    • If the total bilirubin value is more than 1.5 times the upper limit of normal under the screening test
    • If the eGFR calculated by CKD-EPI formula is less than 80 mL/min at screening
    • Subjects showing clinically significant abnormalities on ECG at screening
  3. Allergy and drug abuse

    • Subjects who are hypersensitive to the investigational product or its active ingredient and any other medications (aspirin, antibiotics etc.)
    • Subjects with history of substance abuse or positive results from drug screening test.
  4. Contraindicated drugs/foods

    • Subjects who have been taking any medications (including herbal medicines) or on an abnormal diet (ex: consuming more than 1L of grapefruit juice per day, large amounts of garlic, broccoli and kale, etc.) that can affect the absorption, distribution, metabolism and excretion of the IP within 28 days from the first IP administration date
    • Subjects who took any prescription drugs(ETC) or any over-the-counter drugs(OTC) within 10 days from the first IP administration date
    • Subjects who participated in other clinical trials or bioequivalence test and received other investigational product within 6 months from the first day of the IP administration (allowed to participate only if the other investigational product(s) was(were) not taken)
  5. Blood donation and transfusion

    • Subjects who donated whole blood within 60 days from the first day of the investigational product administration
    • Subjects who received blood transfusion or made apheresis blood donation within 30 days from the first day of the IP administration
  6. Pregnancy, Breastfeeding, and Contraception

    • Women who are pregnant, breast-feeding or have positive result on pregnancy test.
    • Subjects who are unable to use medically proven dual contraceptive methods or medically acceptable contraceptive method (intrauterine device with proven pregnancy failure rate, concurrent use of physical barrier method and spermicide, vasectomy, tubectomy/ligation, and hysterectomy, etc.) by the subject or spouse or partner from the screening date to 30 days after the last IP administration date.
  7. Others

    • Subjects whose weekly alcohol intake exceeds 30g/day in the last 4 weeks prior to the screening visit or found positive on alcohol test
    • Subjects who smoke more than 10 cigarettes/day per week over the last 4 weeks prior to the screening visit
    • Subjects with caffeine consumption of more than 400mg/day per week over the last 4 weeks prior to the screening visit
    • Subjects with clinically significant findings that the investigator determined to be unqualified for participation in the clinical trial
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    T1

    Tegoprazan A mg or placebo

    Drug: Tegoprazan dose A or placebo

  • Experimental
    T2

    Tegoprazan B mg or placebo

    Drug: Tegoprazan dose B or placebo

  • Experimental
    T3

    Tegoprazan C mg or placebo

    Drug: Tegoprazan dose C or placebo

  • Experimental
    T4

    Tegoprazan D mg or placebo

    Drug: Tegoprazan dose D or placebo

Interventions

  • DrugTegoprazan dose A or placebo

    Tegoprazan A mg or placebo taken orally twice daily for 3 days.

  • DrugTegoprazan dose B or placebo

    Tegoprazan B mg or placebo taken orally twice daily for 3 days.

  • DrugTegoprazan dose C or placebo

    Tegoprazan C mg or placebo taken orally twice daily for 3 days.

  • DrugTegoprazan dose D or placebo

    Tegoprazan D mg or placebo taken orally twice daily for 3 days.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics Evaluation

    Cmax of Tegoprazan and M1

    Time frame: Up to 24 hours

  2. Pharmacokinetics Evaluation

    AUC0-t of Tegoprazan and M1

    Time frame: Up to 24 hours

  3. Pharmacokinetics Evaluation

    AUC0-∞ of Tegoprazan and M1

    Time frame: Up to 24 hours

  4. Pharmacokinetics Evaluation

    Tmax of Tegoprazan and M1

    Time frame: Up to 24 hours

  5. Pharmacokinetics Evaluation

    t1/2β of Tegoprazan and M1

    Time frame: Up to 24 hours

  6. Pharmacokinetics Evaluation

    CL/F of Tegoprazan

    Time frame: Up to 24 hours

  7. Pharmacokinetics Evaluation

    Vd/F of Tegoprazan

    Time frame: Up to 24 hours

  8. Pharmacokinetics Evaluation

    Css,max of Tegoprazan and M1

    Time frame: Up to 24 hours

  9. Pharmacokinetics Evaluation

    Css,min of Tegoprazan and M1

    Time frame: Up to 24 hours

  10. Pharmacokinetic Evaluation

    Css,avg of Tegoprazan and M1

    Time frame: Up to 24 hours

  11. Pharmacokinetics Evaluation

    AUC48-72h of Tegoprazan and M1

    Time frame: Up to 24 hours

  12. Pharmacokinetics Evaluation

    Tmax,ss of Tegoprazan and M1

    Time frame: Up to 24 hours

  13. Pharmacokinetics Evaluation

    t1/2β,ss of Tegoprazan and M1

    Time frame: Up to 24 hours

  14. Pharmacokinetics Evaluation

    CLss/F of Tegoprazan

    Time frame: Up to 24 hours

  15. Pharmacokinetics Evaluation

    Vdss/F of Tegoprazan

    Time frame: Up to 24 hours

Secondary outcomes

  1. Pharmacodynamics Evaluation

    Mean pH

    Time frame: 24 hours

  2. Pharmacodynamics Evaluation

    Median pH

    Time frame: 24 hours

  3. Pharmacodynamics Evaluation

    TpH\>4(%)

    Time frame: 24 hours

  4. Pharmacodynamics Evaluation

    TpH\>6(%)

    Time frame: 24 hours

  5. Pharmacodynamics Evaluation

    Basal pH

    Time frame: 24 hours

  6. Pharmacodynamics Evaluation

    Δ TpH\>4(%)

    Time frame: 24 hours

  7. Pharmacodynamics Evaluation

    Δ TpH\>6(%)

    Time frame: 24 hours

  8. Pharmacodynamics Evaluation

    Δ mean pH

    Time frame: 24 hours

  9. Pharmacodynamics Evaluation

    Δ median pH

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • Inje University Busan Paik Hospital
    Busan, 47392, Korea, Republic of
    • Jon Lyul Kim, MD, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04587011
Lead sponsor
HK inno.N Corporation
Responsible party
Sponsor
First posted
Oct 14, 2020
Start date
Sep 24, 2020
Primary completion
Mar 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Dec 28, 2020

Study contacts

Youngshin Keum, R.Ph, Pharm.D
Contact
ys.keum@inno-n.com
+82-2-6477-0204
Seokuee Kim, MD, PhD
Contact
seokuee.kim@inno-n.com
+82-2-6477-0207
Jong Lyul Kim, MD, PhD
principal investigator · Inje University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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