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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Test Drug(JW0302) or Reference Drug(C2206)

• Registration Number: NCT05784155
• Lead Sponsor: JW Pharmaceutical

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study Start: 2023-03-10
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-24
• Primary Completion: 2023-06-09
• Study Completion: 2023-06-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Subjects does not meet the Inclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 2	Test Drug(JW0302) or Reference Drug(C2206)	Reference Drug for Period I Test Drug for Period II
Group 1	Test Drug(JW0302) or Reference Drug(C2206)	Test Drug for Period I Reference Drug for Period II

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of