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OpenTrials
Completed

NCT Number: NCT04278391

Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers

This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 19 aged and 45 aged in healthy male adult
  • Body weight more than 50kg
  • Body Mass Index more than 18.0 and under 27.0

Exclusion criteria

  • Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history
  • Those who have a gastrointestinal disease history that can effect drug absorption or surgery
  • Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product

Treatment and study plan

DWJ1421

Drug

1 tablet administered in fasting condition

DWC201903

Drug

1 tablet administered in fasting condition

Primary outcomes

  1. Cmax

    Time frame: 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h

    Maximum concentration of DWJ1421

  2. AUClast

    Time frame: 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h

    Area under the drug concentration-time curve

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open Label, Single Dose, Crossover Study to Compare the Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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