Clinical trial NCT01526122: Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Keywords: Clopidogrel
Aspirin
coadministration
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 65
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: C(max) of Clopidogrel
timeFrame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
measure: AUC(last) of Clopidogrel
timeFrame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
measure: C(max) of Acetylsalicylic acid
timeFrame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
measure: AUC(last) of Acetylsalicylic acid
timeFrame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
Secondary outcomes:
measure: C(max) of Salicylic acid
timeFrame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
measure: AUC(last) of Salicylic acid
timeFrame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
Other outcomes:
Locations:
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-ran Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Girolamo G, Czerniuk P, Bertuola R, Keller GA. Bioequivalence of two tablet formulations of clopidogrel in healthy Argentinian volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2010 Jan;32(1):161-70. doi: 10.1016/j.clinthera.2010.01.010.
citation: Bae SK, Seo KA, Jung EJ, Kim HS, Yeo CW, Shon JH, Park KM, Liu KH, Shin JG. Determination of acetylsalicylic acid and its major metabolite, salicylic acid, in human plasma using liquid chromatography-tandem mass spectrometry: application to pharmacokinetic study of Astrix in Korean healthy volunteers. Biomed Chromatogr. 2008 Jun;22(6):590-5. doi: 10.1002/bmc.973.
citation: Kim SD, Kang W, Lee HW, Park DJ, Ahn JH, Kim MJ, Kim EY, Kim SW, Nam HS, Na HJ, Yoon YR. Bioequivalence and tolerability of two clopidogrel salt preparations, besylate and bisulfate: a randomized, open-label, crossover study in healthy Korean male subjects. Clin Ther. 2009 Apr;31(4):793-803. doi: 10.1016/j.clinthera.2009.04.017.
citation: EMEA(2009), CHMP assessment report of DuoCover. EMEA/H/C/001144