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Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects

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

NCT05189288•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male volunteers, aged ≥ 19 years old at the time of screening.
•2. 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
•3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
•4. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
•5. Those who agree to contraception during the participation of clinical trial.
•6. 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

•1. 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.
•2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
•3. 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)
•4. Those who have participated in other clinical trials or bioequivalence studies within 6 months of the first administration date and administered the investigational drug
•5. 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
•6. 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
+4 more criteria

Locations (1)

H plus Yangji hospital

Seoul, South Korea

Key Dates

Start Date

January 14, 2022

Primary Completion Date

March 12, 2022

Completion Date

April 15, 2022

Last Updated

September 28, 2022

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis b

Interventions

D418 Tab.

DRUG

CKD-388 Tab.

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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