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Completed

NCT Number: NCT02894541

Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519

The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea university medical center

Seoul, Sungbuk-gu, 136-705, South Korea

About this study

A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 20 aged and 45 aged in healthy adult male
  • Body weight more than 50, Body Mass Index between 18 and 29kg/m²
  • Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
  • Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent

Exclusion criteria

  • Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
  • Have a acute disease within 28 days before the beginning of study treatment
  • Have a disease history that can effect drug absorption, distribution, metabolism, excretion
  • Have a clinically significant chronic disease
  • Systolic blood pressure<100mmHg or>140mmHg, diastolic blood pressure<60mmHg or>90mmHg
  • Defined by the following 12-lead ECG, QTc>450msec
  • Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
  • Subject treated ethical drug within 14 days before the beginning of study treatment
  • Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
  • Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
  • Cannot take standard Meal
  • Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
  • Blood transfusion within 30 days
  • Taking drugs have received any other investigational drug within 90 days prior to the first dosing
  • Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
  • Continuously taking caffeine(caffeine>5 cups/day), drinking alcohol(alcohol>210g/week), smoking excessive cigarettes(cigarette>10cigarettes/day)
  • Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)

Treatment and study plan

CKD-519 100mg

Drug

Other names: CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab)

CKD-519 200mg

Drug

Other names: CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs)

Primary outcomes

  1. Cmax of CKD-519

    Time frame: 0(predose)~168

  2. AUClast of CKD-519

    Time frame: 0(predose)~168

  3. Tmax of CKD-519

    Time frame: 0(predose)~168

  4. AUCinf of CKD-519

    Time frame: 0(predose)~168

  5. T1/2 of CKD-519

    Time frame: 0(predose)~168

  6. CL/F of CKD-519

    Time frame: 0(predose)~168

  7. Vd/F of CKD-519

    Time frame: 0(predose)~168

Secondary outcomes

  1. Inhibition of CETP(Cholesteryl ester transfer protein) Activity

    Time frame: 0(predose)~168

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 1-sequence, 3-treatment, 3-period Crossover Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519 in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 9, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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