A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828

An Open-label, Randomized, Fasted, Single-dose, 2-sequence, 4-period, Replicate Crossover Study to Compare the Pharmacokinetic and Safety Between Administration of CKD-828 20/2.5mg and Administration of D064, D701 in Healthy Adults

A clinical trial to compare the pharmacokinetic and safety of CKD-828

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: CKD-828, D064, D701

Detailed Description

An open-label, randomized, fasted, single-dose, 2-sequence, 4-period, replicate crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-828 20/2.5mg and administration of D064, D701 in healthy adults

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 15079
    • Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult aged ≥ 19 at screening
2. Body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5kg/m2 and Body weight ≥ 55kg
3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
4. A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, urinalysis, serological tests, etc.), vital signs, electrocardiogram examination, etc.
5. A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
6. A person who has agreed to use appropriate contraception and not donate sperm or eggs until 14 days after the first administration of the drug and the last administration of the drug
7. Those who have the ability and willingness to participate during the entire study period

Exclusion Criteria:

1. A history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history of calculus, impacted teeth, wisdom teeth, etc.) or evidence on who has
2. Those with a history of gastrointestinal diseases or surgery (expect simple appendicectomy, hernia surgery, and tooth extraction surgery) that may affect drug absorption ruler

3. A person who shows the following values as a result of conducting a clinical laboratory test

   • ALT or AST > 2 times the upper limit of the normal range
4. Smokers who smoked more than 20 cigarettes a day within 6 months of screening
5. Those who have taken other investigational product or bioequivalence investigational product within 6 months before the first administration of the investigational product

6. Those who meet the following as a result of measuring vital signs at screening

   • Those who have a systolic blood pressure of less than 90 mmHg or more than 140 mmHg or a diastolic blood pressure of less than 60 mmHg or more than 90 mmHg in the sitting position
   • Severe bradycardia (less than 50 beats/min)

7. Those with a history of regular alcohol intake within 1 month of screening

   • More than 14 drinks/week for women
   • More than 21 drinks/week for men
8. A person who has taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of investigational product
9. Those who have taken prescription or non-prescription drugs within 10 days prior to the first administration of investigational product
10. Those who have donated whole blood within 2 months before the first administration of the investigational product, donated component blood within 1 month, received blood transfusion within 1 month, or have plans for the trial during the clinical trial period
11. Those who are judged by the principal investigator (or the person in charge of the test who has been delegated) for reason other than the above selection/exclusion criteria and are judged unsuitable for participation in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D064, D701 - A single oral dose of 2 tablets; Period 2: CKD-828 - A single oral dose of 1 tablet; Period 3: D064, D701 - A single oral dose of 2 tablets; Period 4: CKD-828 - A single oral dose of 1 tablet	Drug: CKD-828, D064, D701; QD, PO
Experimental: Sequence 2; Period 1: CKD-828 - A single oral dose of 1 tablet; Period 2: D064, D701 - A single oral dose of 2 tablets; Period 3: CKD-828 - A single oral dose of 1 tablet; Period 4: D064, D701 - A single oral dose of 2 tablets	Drug: CKD-828, D064, D701; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-828	Area under the concentration-time curve time zero to time	Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours
Cmax of CKD-828	Maximum plasma concentration of the drug	Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: A30_19BE2305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No