To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult Subjects

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Test Drug(JW0302) or Reference Drug(C2206)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: DongRyung Lee, Manager; Phone Number: +82-2-840-6982; Email: dongryung.lee@jw-pharma.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinical Trial Center, Seoul National University Hospital
    • Contact: Ryu HyunWook, Sub-I; Phone Number: +82-2-2072-1666; Email: rhw7052@snu.ac.kr
    • Contact: Lee HyeBin, CRC; Phone Number: +82-2-6072-1441; Email: hblee12280@snu.ac.kr
    • Principal Investigator: Lee SeungHwan, PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Subjects does not meet the Inclusion Criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Test Drug for Period I Reference Drug for Period II	Drug: Test Drug(JW0302) or Reference Drug(C2206); Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration
Other: Group 2; Reference Drug for Period I Test Drug for Period II	Drug: Test Drug(JW0302) or Reference Drug(C2206); Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose	Evaluation PD for ambulatory 24hr pH monitor	Baseline versus Multiple dose during 7 days
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	Evaluation PK for JW0302 and C2206 after multiple dose	up to 24 hours

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: SeungHwan Lee, PI, Clinical Trial Center, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JW22106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No