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.

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.

Study Overview

• Status: Completed
• Conditions: Gastric Ulcer
• Intervention / Treatment: Drug: Vonoprazan Test 20mg; Drug: Vonoprazan Reference 20mg

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Siheung-si, Korea, Republic of
    • Seok Gyeong Medical Foundation Central Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Individuals aged 19 years or older at the time of screening
2. Individuals with no clinically significant congenital or chronic diseases and no pathological symptoms or findings based on medical examinations (such as EEG, ECG, chest and gastric endoscopy, or gastrointestinal radiology tests, if necessary)
3. Individuals deemed suitable for the study based on screening tests (e.g., hematology, blood chemistry, serology, and urinalysis) as determined by the principal investigator (or a designated sub-investigator)
4. Individuals with a Body Mass Index (BMI) between 18.0 and 30.0 (BMI calculation: weight (kg) / height (m)²)
5. Individuals with no history of gastrointestinal surgery that could affect drug absorption.
6. Individuals who, after receiving a detailed explanation of the clinical trial, fully understand the study, voluntarily decide to participate, and agree in writing to comply with the trial requirements during the study period.

Exclusion Criteria:

1. Individuals who have taken enzyme-inducing or inhibiting drugs such as barbiturates within 30 days before the start of the study (first dosing day) or medications that might interfere with the study within 10 days before the start of the study (first dosing day)

2. Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)

   • For men, more than an average of 21 drinks per week
   • For women, more than an average of 14 drinks per week (One drink: 45 mL of distilled spirits or 360 mL of beer or 150 mL of wine)
3. Individuals who have taken any medication that may interfere with the trial within 10 days prior to the start of the trial (first dose).
4. Individuals who have participated in clinical trials (including bioequivalence studies) and received investigational drugs within six months before the start of the study (first dosing day)
5. Individuals who have donated whole blood within 8 weeks or donated blood components within 2 weeks before the start of the study (first dosing day)

6. Patients with the following conditions:

   • Hypersensitivity to the components of this drug
   • Currently taking medications containing atazanavir, nelfinavir, or rilpivirine.
7. Individuals with a history of mental illness
8. Women who may be pregnant, pregnant women, or brestfeeding women

9. Individuals who do not agree to use medically recognized dual contraception* methods, excluding hormonal contraceptives, to prevent pregnancy from the first administration of the investigational drug until one week after the last administration of the investigational drug.

   - Medically recognized dual contraception methods: Combining intrauterine devices (IUD, IUS), vasectomy, tubal ligation, and barrier methods of contraception (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or using two or more barrier methods in combination with spermicides.

10. Individuals deemed unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria by the principal investigator (or a designated sub-investigator)

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 Test 20mg; On the day of the visit, take 1 tablet of the experimental drug orally with 150 mL of water around 8 am.	Drug: Vonoprazan Test 20mg; 1 tablets orally once a day; Other Names: vonoprazan fumarate
Active Comparator: Vonoprazan Reference 20mg; On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am.	Drug: Vonoprazan Reference 20mg; 1 tablets orally once a day; Other Names: Vonoprazna fumarate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Concentration of vonoprazan in plasma	36 hours
Area under the plasma concentration versus time curve (AUC)	Concentration of vonoprazan in plasma	36 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt/AUC∞	Concentration of vonoprazan in plasma	36 hours
Half life	Concentration of vonoprazan in plasma	36 hours
Tmax	Concentration of vonoprazan in plasma	36 hours
AUC ∞	Concentration of vonoprazan in plasma	36 hours

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Stomach Ulcer
• Other Study ID Numbers: DDS23-018BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No