To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

April 8, 2024 updated by: JW Pharmaceutical

A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics and Safety of JW0202 and C2202 or C2205 and JW0201 After Oral Administration in Healthy Volunteers

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Jeonju, Korea, Republic of
        • Clinical Trial Center, Jeonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Subjects does not meet the Inclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1

Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
Drug: Reference Drug or Test Drug
Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration
Other Names:
  • Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)
Other: Group 2

Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
Drug: Reference Drug or Test Drug
Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration
Other Names:
  • Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: Day1 0h ~ Day3 48h
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Day1 0h ~ Day3 48h
Cmax
Time Frame: Day1 0h ~ Day3 48h
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Day1 0h ~ Day3 48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Mingul Kim, Jeonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • JW22104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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