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NCT05784155 Clinical Trial

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

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05784155
Other study ID # JW22106
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 10, 2023
Est. completion date June 26, 2023

Study information
Verified date March 2024
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date June 26, 2023
Est. primary completion date June 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy volunteers Exclusion Criteria: - Subjects does not meet the Inclusion Criteria

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Clinical Trial Center, Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt, 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
Primary 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
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