Clinical trial

A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics and Safety of JW0202 and C2202 or C2205 and JW0201 After Oral Administration in Healthy Volunteers

Name

JW22104

Description

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Trial arms

Trial start

2023-11-03

Estimated PCD

2023-11-20

Trial end

2023-11-27

Status

Completed

Phase

Early phase I

Treatment

Reference Drug or Test Drug

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Arms:

Group 1, Group 2

Other names:

Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)

Size

Primary endpoint

AUCt

Day1 0h ~ Day3 48h

Cmax

Day1 0h ~ Day3 48h

Eligibility criteria

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * Subjects does not meet the Inclusion Criteria

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

Updated at

2024-04-11

1 organization

1 product

1 indication

Organization

JW Pharmaceutical

Product

Reference Drug

Indication

Healthy