Loading clinical trials...

COMPLETEDPHASE1

A Clinical Trial to Evaluate the Food Effect of CKD-379

A Randomized, Open-label, Single-dose, Cross-over Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetic Characteristics and Safety of CKD-379 in Healthy Adult Volunteers

NCT06652971•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

A clinical trial to evaluate the food effect of CKD-379

Detailed Description

A randomized, open-label, single-dose, cross-over phase 1 study to evaluate the effect of food on pharmacokinetic characteristics and safety of CKD-379 in healthy adult volunteers

Eligibility

Age

19 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adult aged 19 or older and 55 or younger at screening
•2. Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
•3. Those with systolic blood pressure ≤ 150 mmHg and ≥ 90 mmHg, diastolic blood pressure ≤ 100 mmHg and ≥ 50 mmHg
•4. A person who has no clinically significant congenital or chronic diseases and has no pathological symptoms or findings as a result of medical examination
•5. A person determined to be suitable for testing as a result of diagnostic tests and electrocardiogram (ECG) established and performed according to the characteristics of the drug during screening
•6. From the date of first administration of the clinical trial drug to the date 7 days after the last administration, either you or your spouse agrees to exclude the possibility of pregnancy using medically appropriate contraception\* and to not provide sperm or eggs
•7. After hearing and fully understanding the full explanation for this clinical trial, the person who voluntarily decides to participate and agrees to comply with the precautions

Exclusion Criteria

•1. A person who has taken a drug metabolase-inducing and inhibiting drug, such as barbitals, within 30 days before the start of the test (the first day of administration), or who has taken a drug that may interfere with the main test within 10 days before the start of the test (the first day of administration)
•2. Anyone who has consumed excessive smoking or caffeine or alcohol within one month prior to the first administration of the clinical trial drug (caffeine: \> 5 cups/day, alcohol: male: \> 21 cups/week, female: \> 14 cups/week, tobacco: \> 20 cigarettes/day), or who cannot stop smoking, caffeine and alcohol consumption during each hospitalization period
•3. Where the tester determines that the drug may affect the test or the safety of the subject, if the drug is administered within 14 days before the first administration of the clinical trial drug or the general drug including health food and vitamin preparations within 7 days
•4. A person who has participated in clinical trials (including biological equivalence tests) and administered experimental drugs within 6 months before the start of the trial (the first dosing date)
•5. A person who has donated whole blood within 8 weeks before the start of the test (the first medication date) or donated ingredients within 2 weeks or received a blood transfusion within 4 weeks
•6. A person who has a history of gastrointestinal diseases (Cron's disease, ulcerative colitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of drugs
•7. A person who has a clinically significant disease or mental illness corresponding to the biliary tract, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood and tumor, cardiovascular system, musculoskeletal system, or has the following manifestations or past history
•* Patients with type 1 diabetes, acute or chronic metabolic acidosis, and those with a history of ketoacidosis (including diabetic ketoacidosis), diabetic comas and total marriages, lactic acidosis, etc
•* Patients with severe heart failure or a history of heart failure (New York Heart Association (NYHA) classification 1,2,3,4 heart conditions)
•* liver dysfunction
+9 more criteria

Locations (1)

Bumin Hospital

Gangseo-gu, Seoul, South Korea

Key Dates

Start Date

November 5, 2024

Primary Completion Date

December 4, 2024

Completion Date

December 17, 2024

Last Updated

December 30, 2024

Enrollment

ACTUAL participants

Conditions

Type II Diabetes Mellitus

Interventions

CKD-379

DRUG

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

NCT07350694

Diabetes Type 2Type II Diabetes Mellitus

View study

RECRUITINGNA

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

NCT06561126

Type II Diabetes MellitusIntermediate Hyperglycemia (IHG)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Clinical Trial to Evaluate the Food Effect of CKD-379

Inclusion Criteria

Exclusion Criteria

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools

An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus