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NCT Number: NCT03609606

A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

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Key information

Conditions

Dyslipidemias Cardiovascular Diseases Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

About this study

An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers aged between ≥ 20 and ≤ 45 years old
  • Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
  • Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
  • Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion criteria

  • History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
  • With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
  • Any medical history that may affect drug absorption, distribution, metabolism and excretion
  • Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
  • Any clinically significant active chronic disease

Treatment and study plan

D013, D326 and D337

Drug

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Other names: CKD-386 Test

D013

Drug

Daily oral administration of 1 tablet under fasting conditions for 7 days

Other names: CKD-386 Reference1

D326 and D337

Drug

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Other names: CKD-386 Reference2

Primary outcomes

  1. AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

  2. Cmax,ss(Maximum plasma concentration of the drug at steady state)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Secondary outcomes

  1. Cmin,ss(Minimum concentration of the drug in plasma at steady state)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

  2. Tmax,ss(Time to maximum plasma concentration at steady state)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

  3. t1/2(Terminal elimination half-life)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

  4. CLss/F(Apparent total body clearance of the drug from plasma at steady state)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

  5. Vd,ss/F(Apparent volume of distribution at steady state)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

  6. PTF(Peak-to-trough fluctuation)

    Time frame: 0(predose)~24 hours at Day7 and Day28

    • Part A: Pharmacokinetic parameter of D013 after multiple dosing
    • Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2018
Registry last updated
Oct 5, 2018

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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