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

NCT07278349 | Completed Phase 1

• 1 other identifier: VON-T003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Erosive Gastritis; Erosive Esophagitis(EE); HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (2)

• 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%

  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%

  48.00 hours

Secondary Outcomes (4)

• AUC0-∞ (Area Under the plasma concentration-time Curve from zero (0) hours to infinity (∞))

  48.00 hours

• Kel (Elimination Rate Constant )

  48.00 hours

• tmax (Time until maximum plasma concentration is reached )

  48.00 hours

• t½el (Plasma concentration half-life)

  48.00 hours

Study Arms (2)

VONOPRAZAN FILM COATED TABLETS

EXPERIMENTAL

VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)

Drug: Vonoprazan Tablets; Drug: VOQUEZNA® Tablets

VOQUEZNA® (VONOPRAZAN) TABLETS

ACTIVE COMPARATOR

VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)

Drug: Vonoprazan Tablets; Drug: VOQUEZNA® Tablets

Interventions

Vonoprazan Tablets DRUG

1 tablet of 20 mg Vonoprazan

VONOPRAZAN FILM COATED TABLETS; VOQUEZNA® (VONOPRAZAN) TABLETS

VOQUEZNA® Tablets DRUG

1 tablet of 20 mg Vonoprazan

VONOPRAZAN FILM COATED TABLETS; VOQUEZNA® (VONOPRAZAN) TABLETS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

IPRC International Pharmaceutical Research Center

Amman, Sport City Circle, 11196, Jordan

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 12, 2025
• Study Start: September 21, 2025
• Primary Completion: October 4, 2025
• Study Completion: December 9, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)