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

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

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

Study Overview

• Status: Completed
• Conditions: HELICOBACTER PYLORI INFECTIONS; Erosive Gastritis; Erosive Esophagitis(EE)
• Intervention / Treatment: Drug: Vonoprazan Tablets; Drug: VOQUEZNA® Tablets

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VONOPRAZAN FILM COATED TABLETS; VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)	Drug: Vonoprazan Tablets; 1 tablet of 20 mg Vonoprazan; Drug: VOQUEZNA® Tablets; 1 tablet of 20 mg Vonoprazan
Active Comparator: VOQUEZNA® (VONOPRAZAN) TABLETS; VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)	Drug: Vonoprazan Tablets; 1 tablet of 20 mg Vonoprazan; Drug: VOQUEZNA® Tablets; 1 tablet of 20 mg Vonoprazan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Humanis Saglık Anonim Sirketi

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2025
• Primary Completion (Actual): October 4, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: VON-T003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No