Clinical Study to Evaluate the Food Effect of CKD-378 in Healthy Volunteers

NCT06709807 | Completed Phase 1

• 1 other identifier: A129_04FDI2412
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-378 in healthy volunteers

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-378

  Area under the CKD-378 concentration in blood-time curve from 0 to t

  0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours

• Cmax of CKD-378

  The maximum CKD-378 concentration in blood sampling time t

  0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours

Study Arms (2)

Fast-Fed

EXPERIMENTAL

Period 1: A single oral dose of 1 tablet under fasting condition, Period 2: A single oral dose of 1 tablet under fed condition

Drug: CKD-378 25/1000mg

Fed-Fast

EXPERIMENTAL

Period 1: A single oral dose of 1 tablet under fed condition, Period 2: A single oral dose of 1 tablet under fasting condition

Drug: CKD-378 25/1000mg

Interventions

CKD-378 25/1000mg DRUG

QD, PO

Fast-Fed; Fed-Fast

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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H Plus Yangji Hospital

Gwanak-gu, Seoul, 08779, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

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: November 26, 2024
• First Posted: November 29, 2024
• Study Start: November 8, 2024
• Primary Completion: December 7, 2024
• Study Completion: December 19, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

KR (1)