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

This study has been completed.
Sponsor:
Collaborator:
Inje University
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01663038
First received: December 20, 2010
Last updated: August 10, 2012
Last verified: August 2012

December 20, 2010
August 10, 2012
December 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01663038 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination
Comparative Pharmacokinetics of Clopidogrel 75mg and Aspirin 100mg After Single Oral Administration as a Fixed Dose Combination Versus Separate Combination in Healthy Male Volunteers

The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • Active Comparator: Clopidogrel and Aspirin
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Copidogrel
    Intervention: Drug: Fixed dose combination of clopidogrel/Aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
January 2011   (final data collection date for primary outcome measure)

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.
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01663038
119HPS10F
No
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Inje University
Principal Investigator: JH Shon, Ph.D Inje University
Chong Kun Dang Pharmaceutical
August 2012

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