An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects

Chong Kun Dang Pharmaceutical1 site in 1 country65 target enrollmentJanuary 14, 2022

ConditionsChronic Hepatitis b

InterventionsD418 Tab.CKD-388 Tab.

DrugsD418 Tab.CKD-388 Tab.

Overview

Phase: Phase 1
Intervention: D418 Tab.
Conditions: Chronic Hepatitis b
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 65
Locations: 1
Primary Endpoint: AUCt of CKD-388, D418
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

Detailed Description

To healthy 60 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Registry

clinicaltrials.gov

Start Date

January 14, 2022

End Date

April 15, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male volunteers, aged ≥ 19 years old at the time of screening.
•Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2 at the time of screening.
•\* BMI = Weight(kg)/ Height(m)2
•Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
•Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
•Those who agree to contraception during the participation of clinical trial.
•Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria

•Those with clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and urogenesis system, mental/nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
•Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
•Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
•Those who have participated in other clinical trials or bioequivalence studies within 6 months of the first administration date and administered the investigational drug
•Those who donated whole blood within 8 weeks of the first dose, or donated component blood within 2 weeks, or received blood transfusion within 4 weeks
•Those who meet the following conditions within 1 month of the first administration date
•In the case of men, alcohol consumption in excess of 21 drinks/week on average
•For women, alcohol consumption in excess of 14 drinks/week on average
•(1 glass = 50 mL of soju or 30 mL of Western liquor or 250 mL of beer)
•Smoking in excess of 20 cigarettes per day on average