Clinical Study to Evaluate the Food Effect of CKD-383 0.5/25/1000mg in Healthy Volunteers (CKD-383 FDI P1)

May 20, 2025 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
QD, PO
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
QD, PO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUCt of CKD-383
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
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, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Cmax of CKD-383
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
The maximum CKD-383 concentration in blood sampling time t
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A101_08FDI2414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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