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

Phase 1CompletedNCT06204107

Chong Kun Dang Pharmaceutical28 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

CKD-379(Empagliflozin+sitagliptin+metformin) Test drugDRUG

oral, once

CKD-379(Empagliflozin+sitagliptin+metformin) Reference drugDRUG

oral, once

Eligibility

Sex: ALLMin age: 19 YearsMax age: 54 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam, South Korea