A Randomized, Open-label, Single Dose, 3-period Partial Replicated Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers Under Fasting Conditions

Chong Kun Dang Pharmaceutical1 site in 1 country51 target enrollmentNovember 11, 2020

ConditionsCardiovascular Disease

InterventionsCKD-333 Tab.CKD-330 Tab. and D090 Tab.

DrugsCKD-330 Tab. and D090 Tab.CKD-333 Tab.

Overview

Phase: Phase 1
Intervention: CKD-333 Tab.
Conditions: Cardiovascular Disease
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 51
Locations: 1
Primary Endpoint: AUCt of CKD-330, D090, CKD-333
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, open-label, single dose, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions.

Detailed Description

To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: 1) Cantabell Tab. 8/5mg 2) Lipitor Tab. 10mg / Test drug: CKD-333 8/5/10mg Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Registry

clinicaltrials.gov

Start Date

November 11, 2020

End Date

April 27, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults over the age of 19 years and under the age of 55 years at the time of screening
•Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 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 following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
•Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
•Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
•Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria

•Individuals with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune diseases.
•Individuals with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
•Individuals with the following laboratory test results at screening:
•ALT or AST \> 2x the upper limit of the normal range
•CK \> 3x the upper limit of the normal range
•History of regular alcohol consumption exceeding 210 g/week within the 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 been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
•Following vital signs results at screening
•Sitting systolic blood pressure ≥ 140 mmHg or \< 90 mmHg and/or sitting diastolic blood pressure ≥90 mmHg or \<60 mmHg