Trials Sponsors Conditions Drugs Pricing

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 TabletsDrug: VOQUEZNA® Tablets

VOQUEZNA® (VONOPRAZAN) TABLETS

ACTIVE COMPARATOR

VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)

Drug: Vonoprazan TabletsDrug: VOQUEZNA® Tablets

Interventions

Vonoprazan TabletsDrug

1 tablet of 20 mg Vonoprazan

VONOPRAZAN FILM COATED TABLETSVOQUEZNA® (VONOPRAZAN) TABLETS

VOQUEZNA® TabletsDrug

1 tablet of 20 mg Vonoprazan

VONOPRAZAN FILM COATED TABLETS

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

IPRC International Pharmaceutical Research Center

Amman, Sport City Circle, 11196, Jordan

MeSH Terms

Interventions

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

Enrollment

28 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.
+8 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

VONOPRAZAN FILM COATED TABLETS

VOQUEZNA® (VONOPRAZAN) TABLETS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

VONOPRAZAN FILM COATED TABLETS

VOQUEZNA® (VONOPRAZAN) TABLETS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations