Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05189288
Other study ID # A99_03BE2122
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 14, 2022
Est. completion date April 15, 2022

Study information

Verified date January 2022
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date April 15, 2022
Est. primary completion date March 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 7. A person who falls under any of the following - Patients with hypersensitivity to this drug or any of its components - Because this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 8. Persons who are judged unsuitable for participation in this clinical trial by the principal investigator (or the authorized study doctor) for reasons other than the above selection/exclusion criteria 9. In the case of female volunteers, those who are pregnant or suspected of being pregnant or are lactating

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
D418 Tab.
1T
CKD-388 Tab.
1T

Locations

Country Name City State
Korea, Republic of H plus Yangji hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUCt of CKD-388, D418 Area under the CKD-388/D418 concentration in blood-time curve from zero to final Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Primary Cmax of CKD-388, D418 The maximum CKD-388/D418 concentration in blood sampling time Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
See also
  Status Clinical Trial Phase
Recruiting NCT04496882 - Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue Phase 4
Completed NCT04083716 - A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults Phase 1
Not yet recruiting NCT03038802 - A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection Phase 1/Phase 2
Completed NCT05310487 - Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects Phase 1
Recruiting NCT06070051 - Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy Phase 1
Terminated NCT05001022 - A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects Phase 1
Recruiting NCT04139850 - The Establishment of Korean Hepatitis B Patients Cohort
Recruiting NCT05343481 - Efficacy of VTP-300 in Chronic Hepatitis B Infection Phase 2
Not yet recruiting NCT05490836 - Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients N/A
Recruiting NCT04543565 - Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study Phase 3
Active, not recruiting NCT02894918 - A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs Phase 4
Not yet recruiting NCT02793791 - Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients N/A
Recruiting NCT02287857 - Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B N/A
Recruiting NCT01965418 - A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial Phase 4
Recruiting NCT01491295 - Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Phase 4
Terminated NCT01872988 - Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma Phase 3
Recruiting NCT01487876 - Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients Phase 2
Completed NCT01531166 - A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon N/A
Not yet recruiting NCT01436539 - Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients Phase 4
Recruiting NCT01360879 - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease N/A