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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04867200

Enrollment

Registered

2021-04-30

Start date

2021-04-27

Completion date

2021-06-01

Last updated

2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant

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.

Interventions

DRUGLixiana(D006)

NOAC(Factor Xa inhibitor)

DRUGCKD-344

NOAC(Factor Xa inhibitor)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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, 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 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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

South Korea

Contacts

Primary ContactYook-Hwan Noh, M.D., PhD.

yook.noh@gmail.com+82-70-4665-9174

Backup ContactYook-Hwan Noh