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NCT05952219 Clinical Trial

Study to Evaluate the Safety and Pharmacokinetics of CKD-379

Type II Diabetes Mellitus Clinical Trial

Official title:
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers Under Fed Conditions

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05952219
Other study ID # A125_04BE2302
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date June 2, 2023
Est. completion date October 30, 2023

Study information
Verified date July 2023
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Description:

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 32
Est. completion date October 30, 2023
Est. primary completion date June 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: - Between 19 aged and 50 aged in healthy adult - 18.0kg/m2=body mass index(BMI)=27.0kg/m2 and 50.0kg=Body weight=90.0kg Exclusion Criteria: - Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system - Have a gastrointestinal disease(Crohn's disease, ulcer etc.) 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-379
2 tablet administration under fed condition
• D759+D745+D029+D150
4 tablet co-administration under fed condition

Locations
Country Name City State
Korea, Republic of Chonbuk National University Hospital Jeonju

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt Maximum plasma concentration of the drug 0~48hours
Primary Cmax Area under the concentration-time curve from the time of dosing to the last measurable concentration 0~48hours
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