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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06204107
Other study ID # A125_05FDI2310
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 21, 2023
Est. completion date December 6, 2023

Study information

Verified date January 2024
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers


Description:

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 6, 2023
Est. primary completion date December 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 54 Years
Eligibility Inclusion Criteria: - Healthy adults aged 19 to 54 years - BMI measurement result is 18.0 kg/m2 to 30 kg/m2 - Written informed consent - Other inclusion criteria, as defined in the protocol Exclusion Criteria: - History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders - AST or ALT or total bilirubin > 1.5 times the upper limit of normal range - History of regular alcohol consumption > 21 units/week within 6 months at the time of screening - Participated in a clinical trial within 6 months prior to 1st IP dosing - Other exclusive inclusion criteria, as defined in the protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam

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 of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
Primary Cmax of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
Secondary AUCinf of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
Secondary Tmax of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
Secondary t1/2 of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
Secondary CL/F of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
Secondary Vd/F of Empagliflozin, sitagliptin, metformin 0 hour ~ 48 hour after drug administration
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