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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06204107
• Other study ID #: A125_05FDI2310
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

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