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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526122

Enrollment

Registered

2012-02-03

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

Clopidogrel, Aspirin, coadministration

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.

Interventions

DRUGG0041(75/100mg)

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

DRUGClopidogrel & Aspirin

Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
C(max) of Clopidogrel	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
AUC(last) of Clopidogrel	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	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	0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

Secondary

Measure	Time frame
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026