Gastric UlcerPhase 1NCT06642987
Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mg(Vonoprazan Fumarate) and Vocinti Tablet 20mg in Healthy Adult Subjects.
A Phase 1 study testing Vonoprazan Test 20mg and Vonoprazan Reference 20mg in people with Gastric Ulcer, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- Vonoprazan Test 20mg and Vonoprazan Reference 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2023to 23 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 19 years or older at the time of screening
- 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)
- 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)
- Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
- Individuals with no history of gastrointestinal surgery that could affect drug absorption.
- 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.
Who cannot join
- 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)
- 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)
- Individuals who have taken any medication that may interfere with the trial within 10 days prior to the start of the trial (first dose).
- 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)
Show all 15Show fewer
- 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)
- Patients with the following conditions:
- Hypersensitivity to the components of this drug
- Currently taking medications containing atazanavir, nelfinavir, or rilpivirine.
- Individuals with a history of mental illness
- Women who may be pregnant, pregnant women, or brestfeeding women
- 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.
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seok Gyeong Medical Foundation Central Hospital
Siheung-si
About this study
Official title: An Open-label, Randomized, Fasting, Single-dose, 2x2, Crossover Study in Healthy Subjects to Evaluate the Bioequivalence of Vonopzan Tablets 20mg(Vonoprazan Fumarate) of Hanlim and Vocinti Tablet 20mg(Vonoprazan Fumarate) of Takeda.
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.
- Conditions
- Gastric Ulcer
- Being tested
- Vonoprazan Test 20mg, Vonoprazan Reference 20mg
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan Test 20mgDrug
Also called vonoprazan fumarate
1 tablets orally once a day
Vonoprazan Reference 20mgDrug
Also called Vonoprazna fumarate
1 tablets orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan Test 20mg | Experimental | On the day of the visit, take 1 tablet of the experimental drug orally with 150 mL of water around 8 am. Receives: Drug: Vonoprazan Test 20mg |
| Vonoprazan Reference 20mg | Active comparator | On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am. Receives: Drug: Vonoprazan Reference 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Concentration of vonoprazan in plasma
Measured: 36 hours
Area under the plasma concentration versus time curve (AUC)
Concentration of vonoprazan in plasma
Measured: 36 hours
Secondary outcomes (4)
AUCt/AUC∞
Concentration of vonoprazan in plasma
Measured: 36 hours
Half life
Concentration of vonoprazan in plasma
Measured: 36 hours
Tmax
Concentration of vonoprazan in plasma
Measured: 36 hours
AUC ∞
Concentration of vonoprazan in plasma
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start23 Oct 2023
- Primary completion3 Nov 2023
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642987
- Sponsor's protocol ID
- DDS23-018BE
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, 2x2, Crossover Study in Healthy Subjects to Evaluate the Bioequivalence of Vonopzan Tablets 20mg(Vonoprazan Fumarate) of Hanlim and Vocinti Tablet 20mg(Vonoprazan Fumarate) of Takeda.
- ClinicalTrials.gov ID
- NCT06642987
- Acronym / sponsor ID
- DDS23-018BE
- Conditions
- Gastric Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan Test 20mg | Experimental | Drug: Vonoprazan Test 20mgOn the day of the visit, take 1 tablet of the experimental drug orally with 150 mL of water around 8 am. |
| Vonoprazan Reference 20mg | Active comparator | Drug: Vonoprazan Reference 20mgOn the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals aged 19 years or older at the time of screening
- 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)
- 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)
- Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
- Individuals with no history of gastrointestinal surgery that could affect drug absorption.
Key exclusion criteria (15 listed)
- 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)
- Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)
- Individuals who have taken any medication that may interfere with the trial within 10 days prior to the start of the trial (first dose).
- 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)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vonoprazan Test 20mgAlso: vonoprazan fumarate1 tablets orally once a day | Drug | Vonoprazan Test 20mg |
| Vonoprazan Reference 20mgAlso: Vonoprazna fumarate1 tablets orally once a day | Drug | Vonoprazan Reference 20mg |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 36 hours
Concentration of vonoprazan in plasma
Area under the plasma concentration versus time curve (AUC)
Time frame: 36 hours
Concentration of vonoprazan in plasma
4 secondary outcomes
AUCt/AUC∞
Time frame: 36 hours
Half life
Time frame: 36 hours
Tmax
Time frame: 36 hours
AUC ∞
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vonoprazan Test 20mg and Vonoprazan Reference 20mg in people with Gastric Ulcer, run by Hanlim 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 6 inclusion and 15 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 16 Oct 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?
Peak Plasma Concentration (Cmax) (time frame: 36 hours). 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?
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 16 Oct 2024.