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Clinical trial

A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults

ID
Name
JW22105
Description
The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers
Trial arms
Trial start
2023-09-10
Estimated PCD
2023-12-23
Trial end
2024-01-13
Status
Completed
Phase
Early phase I
Treatment
Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Arms:
Group 1
Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Arms:
Group 2
Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Arms:
Group 3
Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Arms:
Group 4
Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Arms:
Group 5
Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Arms:
Group 6
Size
48
Primary endpoint
Cmax,ss
Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
AUCτ,ss
Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
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': 48, 'type': 'ACTUAL'}}
Updated at
2024-04-22

1 organization

6 products

1 indication

Organization
JW Pharmaceutical
Product
Group 1: JW0104, C2207, JW0104 + C2207
Indication
Healthy
Product
Group 2: JW0104 + C2207
Product
Group 3: C2207 + JW0104
Product
Group 4: JW0104 + C2207
Product
Group 5: JW0104 + C2207
Product
Group 6: C2207 + JW0104