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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Treatment A_Period 1; Drug: Treatment B_Period 1; Drug: Treatment B_Period 2; Drug: Treatment A_Period 2; Drug: Treatment A_Period 3; Drug: Treatment B_Period 3; Drug: Treatment B_Period 4; Drug: Treatment A_Period 4

• Registration Number: NCT06754943
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study Start: 2025-01
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Subjects does not meet the inclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Treatment A_Period 1	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 1	Treatment B_Period 2	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 1	Treatment A_Period 3	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 1	Treatment B_Period 4	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 2	Treatment B_Period 1	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 2	Treatment A_Period 2	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 2	Treatment B_Period 3	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105
Group 2	Treatment A_Period 4	* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105

Primary Outcome Measures

Name	Time	Method
AUCt	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.
Cmax	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.

Trial Locations

Locations (1)

Metro Hospital; 🇰🇷 Anyang-si, Gyeonni-do, Korea, Republic of