NCT05784155

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 1, 2023

Last Update Submit

March 19, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group 1

OTHER

Test Drug for Period I Reference Drug for Period II

Drug: Test Drug(JW0302) or Reference Drug(C2206)

Group 2

OTHER

Reference Drug for Period I Test Drug for Period II

Drug: Test Drug(JW0302) or Reference Drug(C2206)

Interventions

Test Drug(JW0302) or Reference Drug(C2206)DRUG

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

Group 1Group 2

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

  • SeungHwan Lee, PI

    Clinical Trial Center, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: A randomized, open, single-dose, 2x2 crossover-design clinical trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 24, 2023

Study Start

March 10, 2023

Primary Completion

June 9, 2023

Study Completion

June 26, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)