NCT06754943

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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
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
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
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
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
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
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
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

Timeline

• Start date: 2025-01-17
• Primary completion: 2025-03-24
• Completion: 2025-04-22
• First posted: 2025-01-01
• Last updated: 2025-09-09

Locations

1 site across 1 country: South Korea