Clinical trial

A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0101 and C2101 and Administration of JW0102 in Healthy Volunteers Under Fasting Conditions

Name

JW22101

Description

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions

Trial arms

Trial start

2023-04-28

Estimated PCD

2023-07-10

Trial end

2023-07-17

Status

Completed

Phase

Early phase I

Treatment

Reference Drug or Test Drug

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Arms:

Sequence A, Sequence B

Other names:

Reference Drug(JW0101 and C2101) or Test Drug(JW0102)

Size

Primary endpoint

AUCt

Day1 0h ~ Day4 72h

Cmax

Day1 0h ~ Day4 72h

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': 46, 'type': 'ACTUAL'}}

Updated at

2024-04-09

1 organization

2 products

1 indication

Organization

JW Pharmaceutical

Product

Reference Drug or Test Drug

Indication

Healthy

Product

Reference Drug