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NCT05463497 Clinical Trial

To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05463497
Other study ID # JW21101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 17, 2022
Est. completion date March 23, 2022

Study information
Verified date July 2022
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Description:

1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults. 2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 23, 2022
Est. primary completion date March 16, 2022
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:
• Treatment A
JW0201: single administration, Tablet, Oral, BID for 5 days
• Treatment B
C2103: single administration, Tablet, Oral, BID for 5 days
• Treatment C
JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
• Treatment D
C2104 : single administration, Tablet, Oral, QD for 5 days
• Treatment E
JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days

Locations
Country Name City State
Korea, Republic of Jeonbuk National University Hospita Jeonju Jeollabuk-do

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 Cmax,ss of each drug up to 12hour(or 24hour) after administration
Primary AUCt,ss AUCt,ss of each drug up to 12hour(or 24hour) after administration
Secondary Cmin,ss Cmin,ss of each drug up to 12hour(or 24hour) after administration
Secondary Tmax,ss Tmax,ss of each drug up to 12hour(or 24hour) after administration
Secondary CLss/F CLss/F of each drug up to 12hour(or 24hour) after administration
Secondary Vdss/F Vdss/F of each drug up to 12hour(or 24hour) after administration
Secondary fluctuation fluctuation of each drug up to 12hour(or 24hour) after administration
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