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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

• Registration Number: NCT06204107
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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)

Study Timeline

• Study Start: 2023-11-21
• Primary Completion: 2023-12-06
• Study Completion: 2023-12-06
• Study First Submitted: 2023-12-17
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug	* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug
Group 1	CKD-379(Empagliflozin+sitagliptin+metformin) Test drug	* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug
Group 2	CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug	* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug
Group 2	CKD-379(Empagliflozin+sitagliptin+metformin) Test drug	* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug

Primary Outcome Measures

Name	Time	Method
AUCt of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration

Secondary Outcome Measures

Name	Time	Method
CL/F of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
Tmax of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
t1/2 of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
AUCinf of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration
Vd/F of Empagliflozin, sitagliptin, metformin	0 hour ~ 48 hour after drug administration

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of