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Trial record 13 of 637 for:    ASPIRIN AND clopidogrel

Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration

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: NCT01526122
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 11, 2012
First Posted Date  ICMJE February 3, 2012
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • C(max) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
  • AUC(last) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
  • C(max) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
  • AUC(last) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • C(max) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ]
  • AUC(last) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 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 Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
Official Title  ICMJE A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers
Brief Summary The purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules coadministration in healthy male volunteers.
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 Atherosclerosis
Intervention  ICMJE
  • Drug: G0041(75/100mg)
    G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO
  • Drug: Clopidogrel & Aspirin
    Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO
Study Arms  ICMJE
  • Experimental: G0041(75/100mg)
    Intervention: Drug: G0041(75/100mg)
  • Active Comparator: Clopidogrel & Aspirin
    Intervention: Drug: Clopidogrel & Aspirin
Publications *

*   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: February 1, 2012)
65
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy male volunteers between the ages of 20 to 50 years old
  • weight more than 55kg and within the range of ±20% of IBW
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

  • Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
  • Exceed the normal range of PT, aPTT, BT & platelet counts under 150,000/㎣ or exceed 350,000/㎣
  • Creatinine clearance < 80 mL/min
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption
  • Excessive drinking(exceed 21units/week)
  • Smoking over 10 cigarettes per day
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01526122
Other Study ID Numbers  ICMJE G0041(75/100mg)_AS_Ⅰ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-A ST Co., Ltd.
Study Sponsor  ICMJE Dong-A ST Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young-ran Yoon, M.D., Ph.D. Kyungpook National University Hospital
PRS Account Dong-A ST Co., Ltd.
Verification Date September 2014

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