A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Volunteers

Study Overview
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Brief Summary
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A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344

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

Official Title
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An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Adult Volunteers

Conditions
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Anticoagulant

Intervention / Treatment
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* Drug: Lixiana(D006)
* Drug: CKD-344


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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. 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 8 weeks or blood components within 4 weeks 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1: Reference drug(Lixiana 60 mg) Period 2: Test drug(CKD-344 60 mg) | Drug: Lixiana(D006)<br>* NOAC(Factor Xa inhibitor)<br>* Other names: Reference Drug;Drug: CKD-344<br>* NOAC(Factor Xa inhibitor)<br>* Other names: Test Drug;|
| Experimental: Group B<br>Period 1: Test drug(CKD-344 60 mg) Period 2: Reference drug(Lixiana 60 mg) | Drug: Lixiana(D006)<br>* NOAC(Factor Xa inhibitor)<br>* Other names: Reference Drug;Drug: CKD-344<br>* NOAC(Factor Xa inhibitor)<br>* Other names: Test Drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |