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A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06204107
Enrollment
28
Registered
2024-01-12
Start date
2023-11-21
Completion date
2023-12-06
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief 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

Detailed 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)

Interventions

DRUGCKD-379(Empagliflozin+sitagliptin+metformin) Test drug

oral, once

DRUGCKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

oral, once

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 54 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
AUCt of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration

Secondary

MeasureTime frame
t1/2 of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration
AUCinf of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration
CL/F of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin, sitagliptin, metformin0 hour ~ 48 hour after drug administration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026