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NCT05452525 Clinical Trial

Pharmacokinetics and Safety/Tolerability Profile of CKD-379

Type II Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05452525
Other study ID # A125_01BE2204
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 26, 2022
Est. completion date September 21, 2022

Study information
Verified date October 2022
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/tolerability between CKD-379 tablet and D759, D745, D150 combination

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date September 21, 2022
Est. primary completion date August 27, 2022
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 - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-379 I
1 tablet administration under fed condition
• CKD-379 II
1 tablet administration under fed condition
• D759+D745+D150
3 tablet coadministration under fed condition

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

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 Cmax Maximum plasma concentration of the drug 0~48hours
Primary AUClast Area under the concentration-time curve from the time of dosing to the last measurable concentration 0~48hours
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