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

NCT06754943 — Phase 1, Completed, 60 participants, JW Pharmaceutical

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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

Registry	NCT06754943
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	60 (Actual)
Sponsor	JW Pharmaceutical (Industry)
Conditions	Healthy
Interventions	Treatment A_Period 1, Treatment B_Period 2, Treatment A_Period 3, Treatment B_Period 4, Treatment B_Period 1, Treatment A_Period 2, Treatment B_Period 3, Treatment A_Period 4 (Drug)
Dates	start 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 in South Korea

-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.

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Other	Drug: Treatment A_Period 1; Drug: Treatment B_Period 2; Drug: Treatment A_Period 3; Drug: 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	Other	Drug: Treatment B_Period 1; Drug: Treatment A_Period 2; Drug: Treatment B_Period 3; Drug: 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

Treatment A_Period 1 (Drug), also known as NA (Not Applicable): * 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
Treatment B_Period 2 (Drug), also known as NA (Not Applicable): * 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
Treatment A_Period 3 (Drug), also known as NA (Not Applicable): * 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
Treatment B_Period 4 (Drug), also known as NA (Not Applicable): * 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
Treatment B_Period 1 (Drug), also known as NA (Not Applicable): * 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
Treatment A_Period 2 (Drug), also known as NA (Not Applicable): * 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
Treatment B_Period 3 (Drug), also known as NA (Not Applicable): * 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
Treatment A_Period 4 (Drug), also known as NA (Not Applicable): * 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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 19 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the inclusion Criteria

+Locations (1)

Facility	City	Country	Status
Metro Hospital	Anyang-si, Gyeonni-do	South Korea

+Investigators

Sung-Dae Kwon, Principal investigator, Metro Hospital