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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug; Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT06204107

A125_05FDI2310

Details and patient eligibility

About

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

Full 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)

Enrollment: 28 patients

Sex: All

Ages: 19 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Group 1

Experimental group

Description:

* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug

Treatment:

Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug

Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug

Group 2

Experimental group

Description:

* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug

Treatment:

Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug

Drug: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug