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Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination

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ClinicalTrials.gov Identifier: NCT01663038
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : August 13, 2012
Sponsor:
Collaborator:
Inje University
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE December 20, 2010
First Posted Date  ICMJE August 13, 2012
Last Update Posted Date August 13, 2012
Study Start Date  ICMJE December 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2012)
  • Cmax of clopidogrel/acetylsalicylic acid [ Time Frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h ]
  • AUC of clopidogrel/acetylsalicylic acid [ Time Frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2012)
  • Assess Cmax of salicylic acid. [ Time Frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h ]
  • Assess AUC of salicylic acid. [ Time Frame: Pre-dose, 0.33h, 0.67h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination
Official Title  ICMJE Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers
Brief Summary The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.
Detailed Description Not Provided
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 Coronary Artery Disease
Intervention  ICMJE
  • Drug: Clopidogrel
    Clopidogrel and Aspirin separate combination, single dose
    Other Name: Clopidogrel: Plavix
  • Drug: Fixed dose combination of clopidogrel/Aspirin
    Fixed dose combination of clopidogrel/aspirin
    Other Name: Coprigrel
  • Drug: Aspirin
    Other Name: Aspirin: Astrix
Study Arms  ICMJE
  • Active Comparator: Clopidogrel and Aspirin
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Copidogrel
    Intervention: Drug: Fixed dose combination of clopidogrel/Aspirin
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: August 10, 2012)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
  • Have not any congenital or chronic diseases and medical symptom.
  • Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
  • Able to participate in the entire trial.
  • Signed the informed consent form prior to study participation.

Exclusion Criteria:

  • Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
  • show evidence of acute disease within 28 days prior to the first IP administration.
  • Have the medical history of bleeding symptom or bleeding disease
  • Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
  • Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that does not need medication.
  • Have hypersensitivity reaction histories for Clopidogrel or aspirin.
  • Have abnormal laboratory result. AST or ALT > 1.25 times of upper limit/ Total bilirubin > 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count <150X10^9/L or >350X10^9/L
  • A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
  • Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
  • Have donated whole blood within 60 days prior to the first IP administration.
  • Participated in the other clinical trials within 90days prior to the first IP administration.
  • Take medicine which affect to this trial within 10 days prior to the first IP administration.
  • Appropriate subject for the trial judging from principal investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 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 NCT01663038
Other Study ID Numbers  ICMJE 119HPS10F
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Inje University
Investigators  ICMJE
Principal Investigator: JH Shon, Ph.D Inje University
PRS Account Chong Kun Dang Pharmaceutical
Verification Date August 2012

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