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

C

Chong Kun Dang

Status and phase

Unknown
Phase 1

Conditions

Anticoagulant

Treatments

Drug: Lixiana(D006)
Drug: CKD-344

Study type

Interventional

Funder types

Industry

Identifiers

NCT04867200
A109_02BE2106

Details and patient eligibility

About

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

Full description

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

Enrollment

60 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Group A
Experimental group
Description:
Period 1: Reference drug(Lixiana 60 mg) Period 2: Test drug(CKD-344 60 mg)
Treatment:
Drug: CKD-344
Drug: Lixiana(D006)
Group B
Experimental group
Description:
Period 1: Test drug(CKD-344 60 mg) Period 2: Reference drug(Lixiana 60 mg)
Treatment:
Drug: CKD-344
Drug: Lixiana(D006)

Trial contacts and locations

0

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Central trial contact

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

Data sourced from clinicaltrials.gov

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