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NCT06378684 Clinical Trial

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06378684
Other study ID # JW22105
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 10, 2023
Est. completion date January 13, 2024

Study information
Verified date April 2024
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Description:

Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date January 13, 2024
Est. primary completion date December 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy volunteers Exclusion Criteria: - Subjects does not meet the Inclusion Criteria

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• 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
• 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
• 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
• 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
• 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

Locations
Country Name City State
Korea, Republic of Clinical Trial Center, Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax,ss Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
Primary AUCt,ss Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
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