NCT04673695

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2021

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

November 8, 2020

Last Update Submit

December 16, 2020

Conditions

Anticoagulant

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Lixiana(D006)Drug: CKD-344

Group B

EXPERIMENTAL

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

Drug: Lixiana(D006)Drug: CKD-344

Interventions

Lixiana(D006)DRUG

NOAC(Factor Xa inhibitor)

Also known as: Reference Drug
Group AGroup B
CKD-344DRUG

NOAC(Factor Xa inhibitor)

Also known as: Test Drug
Group AGroup B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yook-Hwan Noh

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Yook-Hwan Noh

    H Plus Yangji Hospital

    STUDY DIRECTOR

Central Study Contacts

Yook-Hwan Noh, M.D., PhD.

CONTACT

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

Yook-Hwan Noh, M.D., PhD.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2020

First Posted

December 17, 2020

Study Start

November 13, 2020

Primary Completion

December 26, 2020

Study Completion

January 2, 2021

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

KR(1)