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

• ClinicalTrials.gov Identifier: NCT01526122
• Recruitment Status: Completed
• First Posted: February 3, 2012
• Last Update Posted: October 1, 2014
• Sponsor: Dong-A ST Co., Ltd.
• Information provided by (Responsible Party): Dong-A ST Co., Ltd.

Study Description

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes 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

Sponsors and Collaborators

Dong-A ST Co., Ltd.

Investigators

• Principal Investigator: Young-ran Yoon, M.D., Ph.D.; Kyungpook National University Hospital

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. 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.

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.

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

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01526122 History of Changes
• Other Study ID Numbers: G0041(75/100mg)_AS_Ⅰ
• First Posted: February 3, 2012
• Last Update Posted: October 1, 2014
• Last Verified: September 2014

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

Clopidogrel; Aspirin; coadministration

Additional relevant MeSH terms:

Aspirin; Clopidogrel; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents