Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration - Full Text View

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis	Drug: G0041(75/100mg) Drug: Clopidogrel & Aspirin	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

C(max) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
AUC(last) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
C(max) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
AUC(last) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

C(max) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
AUC(last) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	September 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526122

Sponsors and Collaborators

Dong-A Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:

Young-ran Yoon, M.D., Ph.D.

Kyungpook National University

More Information

Publications:

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.

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.

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.

Responsible Party:	Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01526122 History of Changes
Other Study ID Numbers:	G0041(75/100mg)_AS_Ⅰ
Study First Received:	January 11, 2012
Last Updated:	February 1, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Dong-A Pharmaceutical Co., Ltd.:

Clopidogrel
Aspirin
coadministration

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists

ClinicalTrials.gov processed this record on June 18, 2013