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 19-100 years
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.