Status:
UNKNOWN
A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Anticoagulant
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344
Detailed Description
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.
Eligibility Criteria
Inclusion
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
- 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 coagulation, blood chemistry, serology, urinalysis) at screening.
- Those who agree to contraception during the participation of clinical trial.
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion
- Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeleto-muscular, immune, etc.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product.
- 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
- 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 γ-GTP.
- Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.
- Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)
- Those who were deemed inappropriate to participate in the study by the investigator.
- Those who have a pregnant or nursing woman.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04673695
Start Date
November 13 2020
End Date
January 2 2021
Last Update
December 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yook-Hwan Noh
Seoul, South Korea