Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04867200
Other study ID # A109_02BE2106
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 27, 2021
Est. completion date June 1, 2021

Study information

Verified date April 2021
Source Chong Kun Dang Pharmaceutical
Contact Yook-Hwan Noh, M.D., PhD.
Phone +82-70-4665-9174
Email yook.noh@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344


Description:

A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 1, 2021
Est. primary completion date May 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Healthy adult volunteers aged = 19 years 2. Weight =60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2 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 coagulation, blood chemistry, serology, urinalysis) at screening. 5. Those who agree to contraception during the participation of clinical trial. 6. Those 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 who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeletomuscular, immune, etc. 2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 3. Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product. 4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 5. Those who donated whole blood within 8 weeks or blood components within 4 weeks prior to the first dose of the investigational product. 6. Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day 7. Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of ?-GTP. 8. Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions. 9. Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.) 10. Those who were deemed inappropriate to participate in the study by the investigator. 11. Those who have a pregnant or nursing woman.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lixiana(D006)
NOAC(Factor Xa inhibitor)
CKD-344
NOAC(Factor Xa inhibitor)

Locations

Country Name City State
Korea, Republic of H+ 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(Area Under Curve last) of CKD-344 Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration. predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Primary Cmax The maximum concentration observed of CKD-344 over blood sampling time. predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
See also
  Status Clinical Trial Phase
Recruiting NCT04010955 - Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)
Recruiting NCT04673695 - A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344 Phase 1
Completed NCT03893591 - A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity
Completed NCT03895502 - Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study Phase 4
Completed NCT03154489 - Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care N/A
Completed NCT04305821 - Medico-economic Interest of the Protein S100b in Mild Head Trauma Under Anti-thrombotics
Recruiting NCT06020560 - Study of Low Molecular Weight Heparins Phase 4
Not yet recruiting NCT05788900 - Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration Phase 1
Not yet recruiting NCT05788913 - Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Subcutaneous Administration Phase 1
Terminated NCT03172546 - Determinants of Oral Anticoagulants' Activity
Not yet recruiting NCT04592822 - A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition Phase 1
Recruiting NCT03772457 - Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
Completed NCT03323320 - Evaluation of Patient's Knowledge of Their NACO Treatment N/A
Recruiting NCT04257487 - Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study) Phase 3
Completed NCT04272723 - Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians