MedTrace Logo

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

NCT06642987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

  • Gastric Ulcer

Interventions

DRUG

Vonoprazan Test 20mg

1 tablets orally once a day

DRUG

Vonoprazan Reference 20mg

1 tablets orally once a day

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2023-11-03
Completion
2024-02-23

Countries

  • South Korea

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642987 on ClinicalTrials.gov