A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Volunteers
NCT ID: NCT04867200
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2021-04-27
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A
1. Period 1: Reference drug(Lixiana 60 mg)
2. Period 2: Test drug(CKD-344 60 mg)
Lixiana(D006)
NOAC(Factor Xa inhibitor)
CKD-344
NOAC(Factor Xa inhibitor)
Group B
1. Period 1: Test drug(CKD-344 60 mg)
2. Period 2: Reference drug(Lixiana 60 mg)
Lixiana(D006)
NOAC(Factor Xa inhibitor)
CKD-344
NOAC(Factor Xa inhibitor)
Interventions
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Lixiana(D006)
NOAC(Factor Xa inhibitor)
CKD-344
NOAC(Factor Xa inhibitor)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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 γ-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.
19 Years
ALL
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Yook-Hwan Noh
Role: PRINCIPAL_INVESTIGATOR
South Korea
Locations
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H+ Yangji Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Yook-HwanYook-Hwan Noh
Role: primary
Other Identifiers
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A109_02BE2106
Identifier Type: -
Identifier Source: org_study_id