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Completed

NCT Number: NCT05452525

Pharmacokinetics and Safety/Tolerability Profile of CKD-379

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 19 aged and 50 aged in healthy adult
  • 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2

Exclusion criteria

  • Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
  • Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
  • Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery
  • Those who are pregnant or breastfeeding
  • Those who are deemed inappropriate to participate in clinical trial by investigators

Treatment and study plan

CKD-379 I

Drug

1 tablet administration under fed condition

CKD-379 II

Drug

1 tablet administration under fed condition

D759+D745+D150

Drug

3 tablet coadministration under fed condition

Primary outcomes

  1. Cmax

    Time frame: 0~48hours

    Maximum plasma concentration of the drug

  2. AUClast

    Time frame: 0~48hours

    Area under the concentration-time curve from the time of dosing to the last measurable concentration

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Oct 18, 2022

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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