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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Atherosclerosis

Treatments: Drug: G0041(75/100mg); Drug: Clopidogrel & Aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526122

G0041(75/100mg)_AS_Ⅰ

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

G0041(75/100mg)

Experimental group

Treatment:

Drug: G0041(75/100mg)

Clopidogrel & Aspirin

Active Comparator group

Treatment:

Drug: Clopidogrel & Aspirin