A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-341 in Healthy Volunteers Under Fasting Conditions

Chong Kun Dang Pharmaceutical1 site in 1 country51 target enrollmentMarch 22, 2024

ConditionsHypertension

InterventionsCKD-341, D956

DrugsCKD-341, D956

Overview

Phase: Phase 1
Intervention: CKD-341, D956
Conditions: Hypertension
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 51
Locations: 1
Primary Endpoint: area under curve(AUC) of CKD-341, D956
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults.

Detailed Description

A randomized, open-label, single dose, 4-period replicate crossover study in healthy adults under fasting conditions

Registry

clinicaltrials.gov

Start Date

March 22, 2024

End Date

May 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults aged between 19 to 55 years at the time of screening.
•Individuals who had 18.0 kg/m2 ≤ Body Mass Index (BMI) \< 30.5 kg/m2 and whose body weight was ≥ 55 kg.
•☞ BMI = weight(kg) / height(m)2
•Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years.
•Individuals who were deemed to be appropriate as study subjects according to the laboratory tests (hematology, blood chemistry, urinalysis, serology, etc.), vital signs, 12-lead electrocardiogram (ECG), etc., performed at screening.
•Individuals who signed an informed consent form approved by the Institutional Review Board (IRB) of Jeonbuk National University Hospital and who decided to participate voluntarily in the study after being fully informed of the study objective, contents, etc. prior to participation.
•Individuals who consented to the use of reliable contraception (contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 1 month after the last administration of investigational product(s).
•Individuals with the ability and willingness to participate the entire study period.

Exclusion Criteria

•Individuals with medical evidence or a history (excluding a simple dental history of dental calculus, impacted tooth, wisdom tooth, etc.) of clinically significant hematological, renal, endocrine, respiratory, gastrointestinal(Active gastric ulcer), duodenal ulcer, etc.), urinary, cardiovascular (severe aortic valve stenosis, aArterial valve, mitral valve stenosis, obstructive hypertrophic cardiomyopathy, etc.), hepatic (severe hepatic impairment, etc.), psychiatric, neurologic, or immune diseases.
•Individuals with a medical history of gastrointestinal diseases (e.g., esophageal disorders such as esophageal achalasia or esophagostenosis, Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction) that may affect drug absorption.
•Individuals with the following laboratory test result at screening:
•ALT or AST \> 2x the upper limit of the normal range
•CK \> 3x the upper limit of the normal range
•eGFR \<60 mL/min/1.73 m2 using CKD-EPI formula
•Individuals with a history of regular alcohol consumption exceeding 210 g/week within 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g).
•Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening.
•Individuals who had taken investigational product(s) from other clinical trials or bioequivalence studies within 6 months prior to the first administration of the investigational product(s).
•Individuals with the following vital signs upon screening