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

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy 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: Reference Drug or Test Drug

Detailed Description

1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation.

   To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.

2. All subjects who received more than one dose of clinical trial drugs are evaluated.

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

Contacts and Locations

• Study Contact: Name: EunJu Kim, SM; Phone Number: +82-2-840-6986; Email: eunju-kim@jw-pharma.co.kr
• Study Contact Backup: 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

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: Reference Drug or Test Drug; Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration; Other Names: Reference Drug(C2105) or Test Drug(JW0301)
Other: Group 2; Reference Drug for Period I Test Drug for Period II	Drug: Reference Drug or Test Drug; Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration; Other Names: Reference Drug(C2105) or Test Drug(JW0301)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	Evaluation PK for Esomeprazole after multiple dose	0 ~ 24h
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

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): June 2, 2022
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): September 14, 2022

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 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: JW21103

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