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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Drug: G0041(75/100mg); Drug: Clopidogrel & Aspirin

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G0041(75/100mg)	Drug: G0041(75/100mg); G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO
Active Comparator: Clopidogrel & Aspirin	Drug: Clopidogrel & Aspirin; Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Young-ran Yoon, M.D., Ph.D., Kyungpook National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• EMEA(2009), CHMP assessment report of DuoCover. EMEA/H/C/001144

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Aspirin; Clopidogrel; coadministration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: G0041(75/100mg)_AS_Ⅰ