Loading clinical trials...

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 2 Tablets and Co-administration of CKD-501, D745 and D150 for Healthy Adult Volunteers in Fasting State

NCT07304726•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-383 in healthy volunteers

Detailed Description

To 30 healthy subjects, following treatments, are administered dosing in each period and wash-out period is 7 days. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Individuals who is 19 years of age or older at the time of the screening visit
•2. Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) \< 30.0 kg/m2 and total body weight ≥ 50 kg BMI = Weight(kg)/ Height(m)2
•3. Individuals who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits
•4. Individuals determined by investigators to be suitable for testing as a result of diagnostic tests and electrocardiogram tests, such as hematology tests, blood chemistry tests, serum tests, urine tests, etc
•5. Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 7 days after the last dose of study drug
•6. Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content

Exclusion Criteria

•1. Individuals who has a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of drugs or has a gastrointestinal disease
•2. Individuals who has used a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first administration of investigational product
•3. Individuals who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational product
•4. Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational product
•5. Individuals who meets the following conditions within one month prior to the first administration of investigational product
•* Man: average alcohol consumption \> 21 cups/weeks
•* Woman: average alcohol consumption \> 14 cups/weeks
•* Smoking \> 20 cigarettes
•6. Patients with the following conditions
•* Patients with hypersensitivity to investigational product or biguanide drugs
+13 more criteria

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

Key Dates

Start Date

October 30, 2025

Primary Completion Date

November 9, 2025

Completion Date

November 23, 2025

Last Updated

December 26, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

CKD-383 0.25/12.5/1000mg

DRUG

CKD-501, D745, D150

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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 26, 2025Data 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

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D