Erosive GastritisPhase 1NCT07278349

Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets

A Phase 1 study testing Vonoprazan Tablets and VOQUEZNA® Tablets in people with Erosive Gastritis and Erosive Esophagitis(EE), run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

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

Randomized, Single Dose, Two-Way Crossover, Open Label bioequivalence study to compare Vonoprazan 20 mg Film Coated Tablets versus Voquezna® 20 mg (Vonoprazan) Tablets an oral administration to healthy adults under fasting conditions Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Erosive Gastritis, Erosive Esophagitis(EE), HELICOBACTER PYLORI INFECTIONS
What is being tested?: Vonoprazan Tablets and VOQUEZNA® Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteJordan
Study dates: 21 Sep 2025to 9 Dec 2025
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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy participant, age 18 to 50 years, inclusive.
Body Mass Index (BMI) range5 is within 18.5 - 30 Kg/m2.
Participant does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
Standard ECG assessment is normal and no QTc Prolongation (QTc ≤ 450 ms in male and QTc ≤ 460 ms in females).
Medical history and physical examination within medically acceptable criteria.
Participant is capable of consent.

Who cannot join

Demographics data with significant deviations from the normal ranges.
Presence of any clinically significant results from laboratory reference ranges, however, ALP and creatinine will be accepted if below reference range after being evaluated by the physician as clinically not significant. RBC count, PCV, MCV, MCH and MCHC with deviation of more than 5% of the reference limits for all laboratory tests that are performed not longer than two weeks before the initiation of the clinical study.
History of drug or alcohol abuse.
Participant is a heavy smoker (more than 10 cigarettes per day).
Participant does not agree to not taking any prescription or non-prescription drugs within at least two weeks before first study drug administration and until donating the last sample of the study.
Participant does not agree to not taking any vitamins taken for nutritional purposes within at least two days before first study drug administration and until donating the last sample of the study.

Show all 23Show fewer

Participant is on a special diet (for example participant is vegetarian).
Participant consumes large quantities of alcohol or beverages containing methyl-xanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.).
Participant does not agree to not consuming any beverages or food containing alcohol at least 2 weeks prior to first study drug administration until donating the last sample of the study.
Participant does not agree to not consuming any beverages or food containing methyl-xanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.) at least 24 hours prior to the study drug administration of either study periods until the end of confinement.
Participant does not agree to not consuming any beverages or food containing grapefruit at least 2 weeks prior to first study drug administration until donating the last sample of the study.
Participant has a history of severe diseases which have direct impact on the study.
Participation in a bioequivalence study or in a clinical study within the last 80 days before first study drug administration.
Participant intends to be hospitalized within 3 months after first study drug administration.
Participants who donated blood or its derivatives in the past 3 months or who through completion of this study, would have donated more than 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Participant has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders.
Participant does not agree to not be engaged in strenuous exercise at least one day prior to study drug administration until donating the last sample in each respective period.
Participant having at screening examination a pulse outside the normal range of (60-100 beats per minute) or a body temperature outside the normal range of (35.0-37.2 °C) or a respiratory rate outside the normal range of (12-20 breaths per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.
Participant has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
Positive blood screen for HIV, Hepatitis B surface antigen (HBsAg), or Hepatitis C.
Participant has a difficulty fasting or consuming standard meals.
The participant is a pregnant or lactating female.
Participant does not agree to not consuming any medication or food which may affect CYP3A4/5, CYP2B6, CYP2C19, CYP2C9 and CYP2D6 enzymes at least two weeks prior to first study drug administration until donating the last sample of the study.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

IPRC International Pharmaceutical Research Center
Amman, Sport City Circle, 11196

Other trials in Jordan

About this study

Official title: Randomized, Single Dose, Two-Way Crossover, Open Label Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets an Oral Administration to Healthy Adults Under Fasting Conditions

Conditions: Erosive Gastritis, Erosive Esophagitis(EE), HELICOBACTER PYLORI INFECTIONS
Being tested: Vonoprazan Tablets, VOQUEZNA® Tablets

What participants receive

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

Vonoprazan TabletsDrug
1 tablet of 20 mg Vonoprazan
VOQUEZNA® TabletsDrug
1 tablet of 20 mg Vonoprazan

Study groups in NCT07278349
Study group	Role	What they receive
VONOPRAZAN FILM COATED TABLETS	Experimental	VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan) Receives: Drug: Vonoprazan Tablets; Drug: VOQUEZNA® Tablets
VOQUEZNA® (VONOPRAZAN) TABLETS	Active comparator	VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan) Receives: Drug: Vonoprazan Tablets; Drug: VOQUEZNA® Tablets

What is being measured

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

Cmax (Maximal Plasma Concentration)
The point estimate and the 90% confidence intervals of the mean values for the Test/Reference ratio were within the bioequivalence acceptable boundaries of 80.00-125.00%
Measured: 48.00 hours
AUC0-t (Area Under the plasma concentration-time Curve from zero (0) hours to time (t) hours)
The point estimate and the 90% confidence intervals of the mean values for the Test/Reference ratio were within the bioequivalence acceptable boundaries of 80.00-125.00%
Measured: 48.00 hours

Secondary outcomes (4)

AUC0-∞ (Area Under the plasma concentration-time Curve from zero (0) hours to infinity (∞))
Descriptive statistics
Measured: 48.00 hours
Kel (Elimination Rate Constant )
Descriptive statistics
Measured: 48.00 hours
tmax (Time until maximum plasma concentration is reached )
Descriptive statistics
Measured: 48.00 hours
t½el (Plasma concentration half-life)
Descriptive statistics
Measured: 48.00 hours

Timeline

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

21 Sep 20259 Dec 2025

First posted12 Dec 2025
Study start21 Sep 2025
Primary completion4 Oct 2025
Study completion9 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Erosive GastritisStudies 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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07278349
Sponsor's protocol ID: VON-T003
Status last verified: Dec 2025
First submitted: 9 Dec 2025
Last updated: 12 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Single Dose, Two-Way Crossover, Open Label Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets an Oral Administration to Healthy Adults Under Fasting Conditions
ClinicalTrials.gov ID: NCT07278349
Acronym / sponsor ID: VON-T003
Conditions: Erosive Gastritis, Erosive Esophagitis(EE), HELICOBACTER PYLORI INFECTIONS
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
Study start: 21 Sep 2025 (actual)
Primary completion: 4 Oct 2025 (actual)
Study completion: 9 Dec 2025 (actual)
First posted: 12 Dec 2025 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VONOPRAZAN FILM COATED TABLETS	Experimental	Drug: Vonoprazan Tablets, Drug: VOQUEZNA® TabletsVONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)
VOQUEZNA® (VONOPRAZAN) TABLETS	Active comparator	Drug: Vonoprazan Tablets, Drug: VOQUEZNA® TabletsVOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy participant, age 18 to 50 years, inclusive.
Body Mass Index (BMI) range5 is within 18.5 - 30 Kg/m2.
Participant does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
Standard ECG assessment is normal and no QTc Prolongation (QTc ≤ 450 ms in male and QTc ≤ 460 ms in females).
Medical history and physical examination within medically acceptable criteria.

Key exclusion criteria (23 listed)

Demographics data with significant deviations from the normal ranges.
Presence of any clinically significant results from laboratory reference ranges, however, ALP and creatinine will be accepted if below reference range after being evaluated by the physician as clinically not significant. RBC count, PCV, MCV, MCH and MCHC with deviation of more than 5% of the reference limits for all laboratory tests that are performed not longer than two weeks before the initiation of the clinical study.
History of drug or alcohol abuse.
Participant is a heavy smoker (more than 10 cigarettes per day).
Participant does not agree to not taking any prescription or non-prescription drugs within at least two weeks before first study drug administration and until donating the last sample of the study.

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 Tablets1 tablet of 20 mg Vonoprazan	Drug	VONOPRAZAN FILM COATED TABLETS, VOQUEZNA® (VONOPRAZAN) TABLETS
VOQUEZNA® Tablets1 tablet of 20 mg Vonoprazan	Drug	VONOPRAZAN FILM COATED TABLETS, VOQUEZNA® (VONOPRAZAN) TABLETS

Primary outcome

Cmax (Maximal Plasma Concentration)
Time frame: 48.00 hours
The point estimate and the 90% confidence intervals of the mean values for the Test/Reference ratio were within the bioequivalence acceptable boundaries of 80.00-125.00%
AUC0-t (Area Under the plasma concentration-time Curve from zero (0) hours to time (t) hours)
Time frame: 48.00 hours
The point estimate and the 90% confidence intervals of the mean values for the Test/Reference ratio were within the bioequivalence acceptable boundaries of 80.00-125.00%

4 secondary outcomes

AUC0-∞ (Area Under the plasma concentration-time Curve from zero (0) hours to infinity (∞))
Time frame: 48.00 hours
Kel (Elimination Rate Constant )
Time frame: 48.00 hours
tmax (Time until maximum plasma concentration is reached )
Time frame: 48.00 hours
t½el (Plasma concentration half-life)
Time frame: 48.00 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 12 Dec 2025.
Individual participant dataSharing planned: No

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 Tablets and VOQUEZNA® Tablets in people with Erosive Gastritis and Erosive Esophagitis(EE), run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.

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 23 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 12 Dec 2025. 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 Jordan. 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 (Maximal Plasma Concentration) (time frame: 48.00 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?

On the ClinicalTrials.gov record for NCT07278349.

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 12 Dec 2025.