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CompletedNCT06642987Updated Oct 16, 2024

Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mg(Vonoprazan Fumarate) and Vocinti Tablet 20mg in Healthy Adult Subjects.

A Phase 1 interventional study of Vonoprazan Test 20mg and Vonoprazan Reference 20mg in Gastric Ulcer, sponsored by Hanlim Pharm. Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by Hanlim Pharm. Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2023, registered Oct 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This clinical trial is an open-label, randomized, fasting, single-dose, two-sequence, two-period, crossover study in healthy subjects to evaluate the bioequivalence of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim Pharm.l Co., Ltd. and "Vocinti Tablet 20 mg (Vonoprazan Fumarate)" of Takeda Pharmaceuticals Korea Co., Ltd. in Healthy Adult Subjects.

Read the detailed description

This study is to compare and evaluate the safety and pharmacokinetic characteristics of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim Pharm. Co., Ltd. as the test drug and "Vocinti Tablet 20 mg (Vonoprazan Fumarate)" of Takeda Pharmaceuticals Korea Co., Ltd. as the reference drug in healthy adults.

02

Conditions studied

  • Gastric Ulcer

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03

In context

Stomach Ulcer

112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 30 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Hanlim Pharm. Co., Ltd. is the lead sponsor of 49 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Individuals aged 19 years or older at the time of screening
  2. Individuals with no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examinations (such as EEG, ECG, chest and gastric endoscopy, or gastrointestinal radiology tests, if necessary)
  3. Individuals deemed suitable for the study based on screening tests (e.g., hematology, blood chemistry, serology, and urinalysis) as determined by the principal investigator (or a designated sub-investigator)
  4. Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
  5. Individuals with no history of gastrointestinal surgery that could affect drug absorption.
  6. Individuals who, after receiving a detailed explanation of the clinical trial, fully understand the study, voluntarily decide to participate, and agree in writing to comply with the trial requirements during the study period.

Exclusion criteria

Exclusion Criteria:

  1. Individuals who have taken enzyme-inducing or inhibiting drugs such as barbiturates within 30 days before the start of the study (first dosing day) or medications that might interfere with the study within 10 days before the start of the study (first dosing day)
  2. Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)

    • For men, more than an average of 21 drinks per week
    • For women, more than an average of 14 drinks per week (One drink: 45 mL of distilled spirits or 360 mL of beer or 150 mL of wine)
  3. Individuals who have taken any medication that may interfere with the trial within 10 days prior to the start of the trial (first dose).
  4. Individuals who have participated in clinical trials (including bioequivalence studies) and received investigational drugs within six months before the start of the study (first dosing day)
  5. Individuals who have donated whole blood within 8 weeks or donated blood components within 2 weeks before the start of the study (first dosing day)
  6. Patients with the following conditions:

    • Hypersensitivity to the components of this drug
    • Currently taking medications containing atazanavir, nelfinavir, or rilpivirine.
  7. Individuals with a history of mental illness
  8. Women who may be pregnant, pregnant women, or brestfeeding women
  9. Individuals who do not agree to use medically recognized dual contraception* methods, excluding hormonal contraceptives, to prevent pregnancy from the first administration of the investigational drug until one week after the last administration of the investigational drug.

    • Medically recognized dual contraception methods: Combining intrauterine devices (IUD, IUS), vasectomy, tubal ligation, and barrier methods of contraception (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or using two or more barrier methods in combination with spermicides.
  10. Individuals deemed unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria by the principal investigator (or a designated sub-investigator)
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Vonoprazan Test 20mg

    On the day of the visit, take 1 tablet of the experimental drug orally with 150 mL of water around 8 am.

    Drug: Vonoprazan Test 20mg

  • Active comparator
    Vonoprazan Reference 20mg

    On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am.

    Drug: Vonoprazan Reference 20mg

Interventions

  • DrugVonoprazan Test 20mg

    1 tablets orally once a day

    Also known as: vonoprazan fumarate

  • DrugVonoprazan Reference 20mg

    1 tablets orally once a day

    Also known as: Vonoprazna fumarate

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Concentration of vonoprazan in plasma

    Time frame: 36 hours

  2. Area under the plasma concentration versus time curve (AUC)

    Concentration of vonoprazan in plasma

    Time frame: 36 hours

Secondary outcomes

  1. AUCt/AUC∞

    Concentration of vonoprazan in plasma

    Time frame: 36 hours

  2. Half life

    Concentration of vonoprazan in plasma

    Time frame: 36 hours

  3. Tmax

    Concentration of vonoprazan in plasma

    Time frame: 36 hours

  4. AUC ∞

    Concentration of vonoprazan in plasma

    Time frame: 36 hours

07

Study locations

1 site
  • Seok Gyeong Medical Foundation Central Hospital
    Siheung-si, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06642987
Lead sponsor
Hanlim Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Oct 23, 2023
Primary completion
Nov 3, 2023
Completion
Feb 23, 2024
Last update
Oct 16, 2024

Oversight

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

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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