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Clinical trial

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

ID
Name
A125_05FDI2310
Description
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
Trial arms
Trial start
2023-11-21
Estimated PCD
2023-12-06
Trial end
2023-12-06
Status
Completed
Phase
Early phase I
Treatment
CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
oral, once
Arms:
Group 1, Group 2
CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
oral, once
Arms:
Group 1, Group 2
Size
28
Primary endpoint
AUCt of Empagliflozin, sitagliptin, metformin
0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin
0 hour ~ 48 hour after drug administration
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}
Updated at
2024-01-12

1 organization

1 product

1 indication

Organization
Chong Kun Dang Pharmaceutical
Product
CKD-379
Indication
Type 2 Diabetes Mellitus