NCT06642987

Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mg(Vonoprazan Fumarate) and Vocinti Tablet 20mg in Healthy Adult Subjects.

An Open-label, Randomized, Fasting, Single-dose, 2x2, Crossover Study in Healthy Subjects to Evaluate the Bioequivalence of Vonopzan Tablets 20mg(Vonoprazan Fumarate) of Hanlim and Vocinti Tablet 20mg(Vonoprazan Fumarate) of Takeda.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is an open-label, randomized, fasting, single-dose, two-sequence, two-period, crossover study in healthy subjects to evaluate the bioequivalence of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim Pharm.l Co., Ltd. and "Vocinti Tablet 20 mg (Vonoprazan Fumarate)" of Takeda Pharmaceuticals Korea Co., Ltd. in Healthy Adult Subjects.

Detailed description

This study is to compare and evaluate the safety and pharmacokinetic characteristics of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim Pharm. Co., Ltd. as the test drug and "Vocinti Tablet 20 mg (Vonoprazan Fumarate)" of Takeda Pharmaceuticals Korea Co., Ltd. as the reference drug in healthy adults.

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	Vonoprazan Test 20mg	1 tablets orally once a day
DRUG	Vonoprazan Reference 20mg	1 tablets orally once a day

Timeline

• Start date: 2023-10-23
• Primary completion: 2023-11-03
• Completion: 2024-02-23
• First posted: 2024-10-15
• Last updated: 2024-10-16

Locations

1 site across 1 country: South Korea