To Evaluate the Safety and PK Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105

September 2, 2025 updated by: JW Pharmaceutical

A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gyeonni-do
      • Anyang-si, Gyeonni-do, South Korea, 14096
        • Metro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Subjects does not meet the inclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
  • Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Treatment B: Administration alone of 1 tablet of JW0105
Drug: Treatment A_Period 1
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Drug: Treatment B_Period 2
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Drug: Treatment A_Period 3
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Drug: Treatment B_Period 4
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Other: Group 2
  • Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Treatment B: Administration alone of 1 tablet of JW0105
Drug: Treatment B_Period 1
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Drug: Treatment A_Period 2
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Drug: Treatment B_Period 3
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)
Drug: Treatment A_Period 4
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions
Other Names:
  • NA (Not Applicable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Cmax
Time Frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Plasma concentrations are measured using a validated LC-MS/MS.
Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Sung-Dae Kwon, Metro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Actual)

March 24, 2025

Study Completion (Actual)

April 22, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW24102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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