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Completed

NCT Number: NCT04354987

Compare the Pharmacokinetics and Safety of CKD-391

phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Jae-Yong Chung

Gyeonggi-do, Seongnam-si, 463-707, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 19 aged and 45 aged in healthy male adult
  • Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
  • Not abnormal or not clinically significant lab values.
  • Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion criteria

  • No history or presence of clinically significant diseases.
  • Subjects showing adverse reaction to investigational product
  • Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
  • History of myopathy
  • unable to stop drinking and smoking during clinical trials
  • Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
  • History of drug abuse
  • Disagree to contraception
  • Subjects who are in any conditions impossible participating in the clinical trials

Treatment and study plan

CKD-391 10/10mg

Drug

Drug T: CKD-391 10/10mg(Other Name: Test Drug)

Other names: Test Drug (T)

D090, D337

Drug

D090 and D337 co-administration(Other Name: Reference drug)

Other names: Reference Drug (R)

Primary outcomes

  1. Cmax

    Time frame: 0~72hours

    To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax

    • Atorvastatin, unconjugated ezetimibe(Cmax)

  2. AUCt

    Time frame: 0~72hours

    To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt

    • Atorvastatin, unconjugated ezetimibe(AUCt)

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D090 and D337 in Healthy Adult Volunteers

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

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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