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

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: Healthy
• Intervention / Treatment: Drug: Treatment A_Period 1; Drug: Treatment B_Period 2; Drug: Treatment A_Period 3; Drug: Treatment B_Period 4; Drug: Treatment B_Period 1; Drug: Treatment A_Period 2; Drug: Treatment B_Period 3; Drug: Treatment A_Period 4

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Sung-Dae Kwon, Metro Hospital

Study record dates

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: Inorganic Chemicals; Metals, Alkali; Elements; Metals, Light; Metals; Sodium
• 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