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

  • STATUS
    Recruiting
  • participants needed
    28
  • sponsor
    Daewoong Pharmaceutical Co. LTD.
Updated on 19 February 2024
chronic disease
electrocardiogram
12 lead electrocardiogram

Summary

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.

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

Details
Condition Healthy
Age 19years - 100years
Treatment DWJ1439, DWJ1464, DWC202003, DWC202004
Clinical Study IdentifierNCT04477369
SponsorDaewoong Pharmaceutical Co. LTD.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy adult volunteers aged 19 years old to under 55
BMI 18.0 and 30 kg/m 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
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    Kyung Hee University Medical Hospital

    Korea, Republic of

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Investigator Avatar
Bo-Hyung Kim

Primary Contact

site
Kyung Hee University Medical Hospital

Korea, Republic of

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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