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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04673695
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
1.6
Anticipated Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 13, 2020
Anticipated Primary Completion Date :
Dec 26, 2020
Anticipated Study Completion Date :
Jan 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Period 1: Reference drug(Lixiana 60 mg) Period 2: Test drug(CKD-344 60 mg)

Drug: Lixiana(D006)
NOAC(Factor Xa inhibitor)
Other Names:
  • Reference Drug

    • Drug: CKD-344
    NOAC(Factor Xa inhibitor)
    Other Names:
  • Test Drug

    		•
    Experimental: Group B

    Period 1: Test drug(CKD-344 60 mg) Period 2: Reference drug(Lixiana 60 mg)

    Drug: Lixiana(D006)
    NOAC(Factor Xa inhibitor)
    Other Names:
  • Reference Drug

    • Drug: CKD-344
    NOAC(Factor Xa inhibitor)
    Other Names:
  • Test Drug

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUCt(Area Under Curve last) of CKD-344 [predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]

      Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.

    2. Cmax [predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose]

      The maximum concentration observed of CKD-344 over blood sampling time.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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, skeleto-muscular, 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 2 months or blood components within 1 month 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yook-Hwan Noh Seoul Korea, Republic of

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Study Director: Yook-Hwan Noh, H Plus Yangji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT04673695
    Other Study ID Numbers:
    • A109_01BE2017
    First Posted:
    Dec 17, 2020
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 17, 2020