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

NCT ID: NCT05433844

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2022-09-14

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Test Drug for Period I Reference Drug for Period II

Group Type: OTHER

Reference Drug or Test Drug

Intervention Type: 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

Group 2

Reference Drug for Period I Test Drug for Period II

Group Type: OTHER

Reference Drug or Test Drug

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Reference Drug(C2105) or Test Drug(JW0301)

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SeungHwan Lee, PI

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Seoul National University Hospital

Locations

Clinical Trial Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

JW21103

Identifier Type: -

Identifier Source: org_study_id