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Completed

NCT Number: NCT06204107

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seongnam, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

oral, once

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

Drug

oral, once

Primary outcomes

  1. AUCt of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

  2. Cmax of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

Secondary outcomes

  1. AUCinf of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

  2. Tmax of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

  3. t1/2 of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

  4. CL/F of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

  5. Vd/F of Empagliflozin, sitagliptin, metformin

    Time frame: 0 hour ~ 48 hour after drug administration

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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