Clinical Study to Evaluate the Food Effect of CKD-383 0.5/25/1000mg in Healthy Volunteers

Last updated: May 20, 2025
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Completed

Phase

1

Condition

Diabetes Mellitus, Type 2

Treatment

CKD-383

Clinical Study ID

NCT06695598
A101_08FDI2414
  • Ages 19-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy adults volunteers between the ages of 19 years to 55 years.

  2. Individuals who had 18.0 kg/m2 ≤ Body Mass Index(BMI) < 30.0 kg/m2 and total bodyweight ≥ 50 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2

  3. Following vital signs results at screening

  • Systolic blood pressure: 90 mmHg to 150 mmHg

  • Diastolic blood pressure: 50 mmHg to 100 mmHg

  1. Individuals who is determined by investigators to be suitable as a test subject as aresult of the examination conducted at the time of screening

  2. Individuals who agreed proper contraception during the study and did consent to notdonation of sperm 7 days after the last dose of study drug

  3. Individuals who signed an informed consent form after being fully informed of thestudy prior to participation, including the objective and content

Exclusion

Exclusion Criteria:

  1. 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, respiratoryfailure, etc.), urinary system, digestive system (such as diarrhea and vomiting),endocrine system, blood and tumor, cardiovascular system (acute myocardialinfarction, shock, acute and unstable heart failure, decompensated heart failure,severe heart failure, or those with a history of heart failure (such as New YorkHeart Association(NYHA) Classification 3 and 4 heart failure)

  2. Acute or chronic metabolic acid patients with type 1 diabetes, lactic acidosis,diabetic ketoacidosis with or without a coma, and diabetic ketoacidosis patients

  3. Patients with diabetic comas and ex-marriage

  4. Individuals who have an acute condition that can change his or her renal function,such as dehydration, before and after surgery, severe infection, severe traumaticsystemic disorder, cardiovascular collapse (shock), sepsis, etc

  5. Patients undergoing intravenous examination of radiodine contrast agents (e.g.,intravenous urinary tract, intravenous cholangiography, angiography, computedtomography with contrast agents, etc.)

  6. Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenalinsufficiency

  7. Individuals who have a history of gastrointestinal diseases (Cron's disease,ulcerative colitis, etc.) or surgery (excluding simple appendectomy or herniasurgery) that may affect the absorption of drugs

  8. Individuals who have a history of clinically significant hypersensitivity reactionsto the main components and components of clinical trial drugs and other drugs (viguanide drugs, thiazolidinedione drugs, etc.)

  9. Individuals who have a history of drug abuse within one year of screening or who hastested positive for a urine drug test

  10. Pregnant women, women who may be pregnant, nursing women

  11. Those who consumed excessive smoking or caffeine or alcohol within one month priorto the first administration of clinical trial drugs (caffeine: >5 cups/day, alcohol:male: >21 cups/week, female: >14 cups/week, tobacco: >20 cigarettes/day), or whocannot stop smoking, caffeine and alcohol consumption during each hospitalizationperiod

  12. If the investigators determines that the drug may affect the clinical trial or thesafety of the subject by administering prescription drugs or herbal medicines within 14 days prior to the first administration of investigational product or generalmedicines including health foods and vitamin preparations within 7 days

  13. Individuals who have taken a drug metabolase-inducing and inhibiting drug, such asbarbitals, within 30 days prior to the first administration of investigationalproduct

  14. Individuals who had been administered investigational product from other clinicalstudy(include bioequivalence study) within the 6 months prior to the firstadministration of investigational drugs

  15. Individuals who donated whole blood within the 8 weeks, or blood components within 2weeks or had a blood transfusion within 30 days prior to the first administration ofinvestigational drugs

  16. Those who are deemed insufficient to participate in this clinical study byinvestigators

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: CKD-383
Phase: 1
Study Start date:
November 06, 2024
Estimated Completion Date:
December 19, 2024

Study Description

To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is 7 days

Connect with a study center

  • Bumin Hospital

    Gangseo-gu, Seoul 07590
    Korea, Republic of

    Site Not Available

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