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Pharmacokinetic Drug-drug Interaction of CKD-330 and D086

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017950
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE December 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • AUCτ,ss of Candesartan and Amlodipine [ Time Frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30 ]
  • AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin [ Time Frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03017950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Drug-drug Interaction of CKD-330 and D086
Official Title  ICMJE Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers
Brief Summary The purpose of the study is examining and comparing the pharmacokinetic drug interaction and safety of both single administration and combination administration of CKD-330 and D086 to healthy male subjects
Detailed Description

An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study

Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330 affects pharmacokinetics of D086.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Hyperlipidemias
Intervention  ICMJE
  • Drug: CKD-330
  • Drug: D086
  • Drug: CKD-330 + D086
Study Arms  ICMJE
  • Experimental: Part1 (A)

    Number of Subjects: 10

    Number of days for Period 1: 8

    Number of days for Period 2: 8

    Number of days for wash-out between period 1 and period 2: 14

    IPs for Period 1: CKD-330

    IPs for Period 2: CKD-330 + D086

    Interventions:
    • Drug: CKD-330
    • Drug: CKD-330 + D086
  • Experimental: Part1 (B)

    Number of Subjects: 10

    Number of days for Period 1: 8

    Number of days for Period 2: 8

    Number of days for wash-out between period 1 and period 2: 14

    IPs for Period 1: CKD-330 + D086

    IPs for Period 2: CKD-330

    Interventions:
    • Drug: CKD-330
    • Drug: CKD-330 + D086
  • Experimental: Part2 (A)

    Number of Subjects: 30

    Number of days for Period 1: 8

    Number of days for Period 2: 8

    Number of days for wash-out between period 1 and period 2: 14

    IPs for Period 1: D086

    IPs for Period 2: CKD-330 + D086

    Interventions:
    • Drug: D086
    • Drug: CKD-330 + D086
  • Experimental: Part2 (B)

    Number of Subjects: 30

    Number of days for Period 1: 8

    Number of days for Period 2: 8

    Number of days for wash-out between period 1 and period 2: 14

    IPs for Period 1: CKD-330 + D086

    IPs for Period 2: D086

    Interventions:
    • Drug: D086
    • Drug: CKD-330 + D086
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2017)
83
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
80
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adult males age of between 19 - 45 on the day of screening.
  2. Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
  3. 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.
  4. Not abnormal or not clinically significant lab values.
  5. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

  1. No history or presence of clinically significant cardiac, respiratory, neurological, endocrine, metal and renal diseases and liver and kidney diseases.
  2. Subjects showing angioedema as an adverse reaction to ACE inhibitors
  3. Primary Hyperaldosteronism
  4. History or family history of myopathy
  5. Subjects with mental diseases or drug addiction
  6. Allergic reactions to candesartan or amlodipine or atorvastatin
  7. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
  8. Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg) on the day of screening
  9. Subjects who experienced gastrointestinal diseases or surgeries which can affect absorption of Investigational product
  10. Subjects with abnormal lab values at least one below

    (AST or ALT>2 fold of upper normal limit, Total bilirubin>2 fold of upper normal limit, CPK>2 fold of upper normal limit, K <3.5mEq/L or >5.5mEq/L, Estimated Glomerular filtration rate<60mL/min/1.73m2 by Modification)

  11. Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy smoker(> 10 cigarettes per day) and unable to stop drinking during clinical trials
  12. Subjects who previously participated in other clinical trials within 90 days
  13. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
  14. Subjects who were administered below medications within 30 days (cyclosporin, erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole, rifampicin, barbiturate : theses medicines could affect absorption, metabolism, distribution and excretion of candesartan,amlodipine and atorvastatin)
  15. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
  16. Subjects who have taken any diets affecting absorption, metabolism, distribution and excretion of investigational products (especially grapefruit juice).
  17. Subjects who are in conditions impossible participating in the clinical trials following other laboratory tests.
  18. Unable to use contraceptions.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03017950
Other Study ID Numbers  ICMJE 170DDI16017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chong Kun Dang Pharmaceutical
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP