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OpenTrials
Completed

NCT Number: NCT03793985

Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337

Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination

Completed

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Key information

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

INHA University Hospital

Incheon, 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
  • Over 50 kg, BMI between 18.0-29.0 kg/m2
  • 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
  • Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2
  • Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
  • Smoke over 10 cigarettes per day or unable to stop smoking
  • Subjects who previously participated in other clinical trials within 90 days
  • Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
  • Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
  • Taking medications which induce or block medication metabolism
  • History of drug abuse
  • Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
  • Disagree to contraception
  • Subjects who are in any conditions impossible participating in the clinical trials

Treatment and study plan

T

Drug

CKD-391 40/10mg

Other names: Test Drug

R

Drug

D086 and D337 co-administration

Other names: Reference drug

Primary outcomes

  1. Cmax

    Time frame: 0~72hours

    To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax

  2. AUCt

    Time frame: 0~72hours

    To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2019
Registry last updated
Jan 7, 2019

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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