An Open Label, Randomized, Single Dose, Crossover, Phase I Study to Evaluate the Effects of Food on Pharmacokinetics and the Safety of CKD-383 in Healthy Adult Volunteers

Chong Kun Dang Pharmaceutical1 site in 1 country30 target enrollmentNovember 6, 2024

ConditionsType 2 Diabetes Mellitus (T2DM)

InterventionsCKD-383

DrugsCKD-383

Overview

Phase: Phase 1
Intervention: CKD-383
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 30
Locations: 1
Primary Endpoint: AUCt of CKD-383
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the food effect 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

Registry

clinicaltrials.gov

Start Date

November 6, 2024

End Date

December 13, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults volunteers between the ages of 19 years to 55 years.
•Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) \< 30.0 kg/m2 and total body weight ≥ 50 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
•Following vital signs results at screening
•Systolic blood pressure: 90 mmHg to 150 mmHg
•Diastolic blood pressure: 50 mmHg to 100 mmHg
•Individuals who is determined by investigators to be suitable as a test subject as a result of the examination conducted at the time of screening
•Individuals who agreed proper contraception during the study and did consent to not donation of sperm 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

Exclusion Criteria

•Clinically significant biliary tract (such as hepatic dysfunction, liver failure, etc.), kidney (stage 3b), and severe renal impairment (eGFR \<60 mL/min/1.73 m2), nervous system, immune system, respiratory system (such as pulmonary infarction, severe pulmonary dysfunction and other hypoxemia prone conditions, respiratory failure, etc.), urinary system, digestive system (such as diarrhea and vomiting), endocrine system, blood and tumor, cardiovascular system (acute myocardial infarction, shock, acute and unstable heart failure, decompensated heart failure, severe heart failure, or those with a history of heart failure (such as New York Heart Association(NYHA) Classification 3 and 4 heart failure)
•Acute or chronic metabolic acid patients with type 1 diabetes, lactic acidosis, diabetic ketoacidosis with or without a coma, and diabetic ketoacidosis patients
•Patients with diabetic comas and ex-marriage
•Individuals who have an acute condition that can change his or her renal function, such as dehydration, before and after surgery, severe infection, severe traumatic systemic disorder, cardiovascular collapse (shock), sepsis, etc
•Patients undergoing intravenous examination of radiodine contrast agents (e.g., intravenous urinary tract, intravenous cholangiography, angiography, computed tomography with contrast agents, etc.)
•Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
•Individuals who have 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
•Individuals who have a history of clinically significant hypersensitivity reactions to the main components and components of clinical trial drugs and other drugs (viguanide drugs, thiazolidinedione drugs, etc.)
•Individuals who have a history of drug abuse within one year of screening or who has tested positive for a urine drug test
•Pregnant women, women who may be pregnant, nursing women