A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer

Chong Kun Dang Pharmaceutical1 site in 1 country36 target enrollmentFebruary 26, 2019

ConditionsRheumatoid Arthritis

InterventionsD569 Tab.CKD-374 5mg Tab.

DrugsD569 Tab.CKD-374 5mg Tab.

Overview

Phase: Phase 1
Intervention: D569 Tab.
Conditions: Rheumatoid Arthritis
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 36
Locations: 1
Primary Endpoint: Cmax of CKD-374 and D569
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.

Detailed Description

To healthy subjects of thirty-six (36), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed

Registry

clinicaltrials.gov

Start Date

February 26, 2019

End Date

May 8, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subject older than 19 years and less than 55 years at the screening
•Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and a total body weight ≥ 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 in accordance with the screening results (laboratory tests, vital signs, ECG, chest X-ray etc.)
•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 drug
•Individuals with the ability and willingness to participate during the study period

Exclusion Criteria

•Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
•Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
•Individuals with the following laboratory test results: ALT or AST \> 2x the upper limit of the normal range
•A 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) of other clinical study or bioequivalence study within the 3 months prior to the first dose of this study
•Individuals with the following vital signs results at screening
•\*Individuals who had sitting blood pressure ≥90 mmHg or \<140 mmHg (systolic) or ≥90 mmHg or \<60 mmHg (diastolic)
•Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
•Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)