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

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment B_Period 1; Drug: Treatment B_Period 3; Drug: Treatment A_Period 4; Drug: Treatment A_Period 1; Drug: Treatment B_Period 4; Drug: Treatment A_Period 3; Drug: Treatment A_Period 2; Drug: Treatment B_Period 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06754943

JW24102

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• Subjects does not meet the inclusion Criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group 1

Other group

Description:

* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105

Treatment:

Drug: Treatment B_Period 2

Drug: Treatment A_Period 3

Drug: Treatment B_Period 4

Drug: Treatment A_Period 1

Group 2

Other group

Description:

* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105

Treatment:

Drug: Treatment A_Period 2

Drug: Treatment A_Period 4

Drug: Treatment B_Period 3

Drug: Treatment B_Period 1