NCT07278349

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Vonoprazan Tablets	1 tablet of 20 mg Vonoprazan
DRUG	VOQUEZNA® Tablets	1 tablet of 20 mg Vonoprazan

Timeline

• Start date: 2025-09-21
• Primary completion: 2025-10-04
• Completion: 2025-12-09
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: Jordan