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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Reference Drug or Test Drug

• Registration Number: NCT05433844
• 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

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 Timeline

• Study Start: 2022-06-02
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Primary Completion: 2022-08-26
• Study Completion: 2022-09-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

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 1	Reference Drug or Test Drug	Test Drug for Period I Reference Drug for Period II
Group 2	Reference Drug or Test Drug	Reference Drug for Period I Test 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)	0 ~ 24h	Evaluation PK for Esomeprazole 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