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NCT06355349 Clinical Trial

To Evaluate the Safety and PK Characteristics in Healthy Volunteers

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06355349
Other study ID # JW22101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 28, 2023
Est. completion date July 17, 2023

Study information
Verified date March 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 characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions

Description:

Pharmacokinetic characteristics: 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 46
Est. completion date July 17, 2023
Est. primary completion date July 10, 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:
• Reference Drug or Test Drug
Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Locations
Country Name City State
Korea, Republic of Clinical Trial Center, Jeonbuk National University Hospital Jeonju

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 AUCt Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Day1 0h ~ Day4 72h
Primary Cmax Describes the blood concentration statistically by pharmacokinetic blood Day1 0h ~ Day4 72h
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