Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin

NCT01388660 | Unknown Phase 1

• 1 other identifier: BCA006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin and the simultaneous administration of the separate formulations of the two drugs in healthy male volunteers.

Conditions

Coronary Artery Disease

Keywords

Healthy; Platelet Aggregation Inhibitors; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid

  Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings

  upto 24 hours after dosing

Study Arms (2)

Cloas

EXPERIMENTAL

A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin

Drug: Cloas

Plavix/Astrix

ACTIVE COMPARATOR

Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)

Drug: Plavix/Astrix

Interventions

Cloas DRUG

A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, PO, 2 tablet once daily for Period I \& II Day 1 (crossover manner)

Cloas

Plavix/Astrix DRUG

Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin), 2 tablets once daily for Period I \& II Day 1 (crossover manner)

Plavix/Astrix

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 20 - 45 years
• With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9}
• Agreement with written informed consent

You may not qualify if:

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
• Subject with symptoms of acute disease within 28 days of starting administration of investigational drug
• Subject with known for history which affect on the ADME of drug Clinically significant active chronic disease
• Inadequate result of laboratory test (especially, Platelet count \< 150,000, Platelet count \> 350,000, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL)
• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
• Taking OTC(Over the counter)medicine including oriental medicine within 7 days
• Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
• Subject with known for hypersensitivity reaction to clopidogrel or aspirin analog
• Not able to taking the institutional standard meal
• Previously make whole blood donation within 60 days or component blood donation within 30 days
• Previously participated in other trial within 90 days
• Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 433-721, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Doo-Yeoun Cho, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doo-Yeoun Cho, MD

CONTACT

+82-31-219-4271; dooycho@ajou.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

KR (1)