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

NCT07304726 | Completed Phase 1

• 1 other identifier: A101_11BE2509
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Cmax of CKD-383

  The maximum CKD-383 concentration in blood sampling time t

  0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

• AUCt of CKD-383

  Area under the CKD-383 concentration in blood-time curve from 0 to t

  0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Study Arms (2)

RT

EXPERIMENTAL

Period 1: A single oral dose of 4 tablets under fasting condition(CKD-501(1T), D745(1T), D150(2T)), Period 2: A single oral dose of 2 tablets under fasting condition(CKD-383)

Drug: CKD-383 0.25/12.5/1000mg; Drug: CKD-501, D745, D150

TR

EXPERIMENTAL

Period 1: A single oral dose of 2 tablets under fasting condition(CKD-383), Period 2: A single oral dose of 4 tablets under fasting condition(CKD-501(1T), D745(1T), D150(2T))

Drug: CKD-383 0.25/12.5/1000mg; Drug: CKD-501, D745, D150

Interventions

CKD-383 0.25/12.5/1000mg DRUG

QD, PO

Also known as: Test

RT; TR

CKD-501, D745, D150 DRUG

QD, PO

Also known as: Reference

RT; TR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who is 19 years of age or older at the time of the screening visit
• 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
• 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
• 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
• 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
• Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content

You may not qualify if:

• 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
• 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
• 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
• 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
• 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
• Patients with the following conditions
• Patients with hypersensitivity to investigational product or biguanide drugs
• Patients with acute or chronic metabolic acidosis including type 1 diabetes, lactic acidosis, comatose or not diabetic ketoacidosis, and patients with a history of ketoacidosis
• Acute conditions that can affect renal functions such as moderate (stage3b) and severe renal impairment (glomerular filtration rate \<45ml/min/1.73m2), dehydration, severe infection, cardiovascular despondency (shock), acute myocardial infarction, sepsis, etc
• Patients with acute and unstable heart failure or severe heart failure or a history of heart failure
• Patients undergoing tests for intravenous administration of radioiodine contrast agents (e.g., intravenous urinary tract, intravenous cholangiography, angiography, computed tomography with contrast agents, etc.)
• Diabetic coma and pre-coma

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 26, 2025
• Study Start: October 30, 2025
• Primary Completion: November 9, 2025
• Study Completion: November 23, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)