Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers

July 27, 2020 updated by: Daewoong Pharmaceutical Co. LTD.

An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University Medical Hospital
        • Contact:
          • Bo-Hyung Kim

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult volunteers aged 19 years old to under 55.
  • BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
  • Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
  • Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
  • Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

  • Known history or presence of any clinically significant medical condition.
  • Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
  • Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
  • Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
  • Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
Drug: DWJ1439
300mg single dose
Drug: DWJ1464
300mg single dose
Drug: DWC202003
300mg single dose
Other: Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
Drug: DWJ1464
300mg single dose
Drug: DWC202003
300mg single dose
Drug: DWC202004
300mg single dose
Other: Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
Drug: DWJ1439
300mg single dose
Drug: DWC202003
300mg single dose
Drug: DWC202004
300mg single dose
Other: Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
Drug: DWJ1439
300mg single dose
Drug: DWJ1464
300mg single dose
Drug: DWC202004
300mg single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
Time Frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
Time Frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
Time Frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
Time Frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
0 - 72 hours after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf
Time Frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from drug administration to drug elimination
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax
Time Frame: 0 - 72 hours after dosing
Time to reach maximum plasma concentration following drug administration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2
Time Frame: 0 - 72 hours after dosing
Elimination half-life
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F
Time Frame: 0 - 72 hours after dosing
Apparent total clearance of drug from plasma after oral administration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F
Time Frame: 0 - 72 hours after dosing
Apparent volume of distribution after oral administration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf
Time Frame: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from drug administration to drug elimination
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax
Time Frame: 0 - 72 hours after dosing
Time to reach maximum plasma concentration following drug administration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2
Time Frame: 0 - 72 hours after dosing
Elimination half-life
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F
Time Frame: 0 - 72 hours after dosing
Apparent total clearance of drug from plasma after oral administration
0 - 72 hours after dosing
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F
Time Frame: 0 - 72 hours after dosing
Apparent volume of distribution after oral administration
0 - 72 hours after dosing

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daewoong Pharmaceutical Co. LTD.

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DW_DWJ1464101

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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