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

NCT05834595 | Completed Phase 1

• 1 other identifier: A30_19BE2305
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

* 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

Sequence 2

EXPERIMENTAL

* 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

Interventions

CKD-828, D064, D701 DRUG

QD, PO

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult aged ≥ 19 at screening
• Body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5kg/m2 and Body weight ≥ 55kg
• Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
• 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.
• 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
• 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
• Those who have the ability and willingness to participate during the entire study period

You may not qualify if:

• 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
• Those with a history of gastrointestinal diseases or surgery (expect simple appendicectomy, hernia surgery, and tooth extraction surgery) that may affect drug absorption ruler
• 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
• Smokers who smoked more than 20 cigarettes a day within 6 months of screening
• Those who have taken other investigational product or bioequivalence investigational product within 6 months before the first administration of the investigational product
• 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)
• 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
• 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
• Those who have taken prescription or non-prescription drugs within 10 days prior to the first administration of investigational product
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Central hospital

Gyeonggi-do, 15079, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: May 2, 2023
• Primary Completion: July 18, 2023
• Study Completion: July 26, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)