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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526122
• Other study ID #: G0041(75/100mg)_AS_?
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2012
• Last updated: September 29, 2014
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• G0041(75/100mg)
G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO
• Clopidogrel & Aspirin
Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C(max) of Clopidogrel		0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h	No
Primary	AUC(last) of Clopidogrel		0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h	No
Primary	C(max) of Acetylsalicylic acid		0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h	No
Primary	AUC(last) of Acetylsalicylic acid		0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h	No
Secondary	C(max) of Salicylic acid		0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h	No
Secondary	AUC(last) of Salicylic acid		0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h	No