To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Test Drug(JW0302) or Reference Drug(C2206)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05784155

JW22106

Details and patient eligibility

About

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Enrollment: 44 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: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Group 1

Other group

Description:

Test Drug for Period I Reference Drug for Period II

Treatment:

Drug: Test Drug(JW0302) or Reference Drug(C2206)

Group 2

Other group

Description:

Reference Drug for Period I Test Drug for Period II

Treatment:

Drug: Test Drug(JW0302) or Reference Drug(C2206)