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CompletedNCT06695598CKD-383 FDI P1Updated May 21, 2025

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

A Phase 1 interventional study of CKD-383 in Type 2 Diabetes Mellitus (T2DM), sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 body weight ≥ 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
  4. 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
  5. 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
  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

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, 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)
  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 traumatic systemic disorder, cardiovascular collapse (shock), sepsis, etc
  5. Patients undergoing intravenous examination of radiodine contrast agents (e.g., intravenous urinary tract, intravenous cholangiography, angiography, computed tomography with contrast agents, etc.)
  6. Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency
  7. 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
  8. 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.)
  9. Individuals who have a history of drug abuse within one year of screening or who has tested 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 prior to 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 who cannot stop smoking, caffeine and alcohol consumption during each hospitalization period
  12. If the investigators determines that the drug may affect the clinical trial or the safety of the subject by administering prescription drugs or herbal medicines within 14 days prior to the first administration of investigational product or general medicines including health foods and vitamin preparations within 7 days
  13. Individuals who have taken a drug metabolase-inducing and inhibiting drug, such as barbitals, within 30 days prior to the first administration of investigational product
  14. Individuals who had been administered investigational product from other clinical study(include bioequivalence study) within the 6 months prior to the first administration of investigational drugs
  15. Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 30 days prior to the first administration of investigational drugs
  16. Those who are deemed insufficient to participate in this clinical study by investigators
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Fast-Fed

    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-383

  • Experimental
    Fed-Fast

    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-383

Interventions

  • DrugCKD-383

    QD, PO

06

What researchers measure

Primary outcomes

  1. AUCt of CKD-383

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

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours

  2. Cmax of CKD-383

    The maximum CKD-383 concentration in blood sampling time t

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours

07

Study locations

1 site
  • Bumin Hospital
    Gangseo-gu, Seoul 07590, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06695598
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Nov 6, 2024
Primary completion
Dec 8, 2024
Completion
Dec 19, 2024
Last update
May 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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