Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2014 by Ajou University School of Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ajou University School of Medicine
Information provided by (Responsible Party):
Doo-Yeoun Cho, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01388660
First received: July 5, 2011
Last updated: March 25, 2014
Last verified: March 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Cloas Drug: Plavix/Astrix |
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 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 |
Resource links provided by NLM:
Further study details as provided by Ajou University School of Medicine:
Primary Outcome Measures:
- Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid [ Time Frame: upto 24 hours after dosing ] [ Designated as safety issue: No ]Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cloas
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
|
Drug: Cloas
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)
|
|
Active Comparator: Plavix/Astrix
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
|
Drug: Plavix/Astrix
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)
|
Detailed Description:
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou Medical Center on the day before dosing, and they will overnight-fasted from 10 p.m. of Day -1.
Subjects will be dosed study drug (a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, or the simultaneous administration of the separate formulations of the two drugs) orally with 240 mL of water around 8 a.m. of Day 1. Subjects will be performed scheduled pharmacokinetic sampling upto 24 hours.
After 2 weeks of washout period, Subjects will be dosed study drug by crossover manner, and will be performed scheduled pharmacokinetic sampling upto 24 hours.
Study participation will be ended on post-study visit (Day 25).
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388660
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388660
Contacts
| Contact: Doo-Yeoun Cho, MD | +82-31-219-4271 | dooycho@ajou.ac.kr |
Locations
| Korea, Republic of | |
| Ajou University School of Medicine | Recruiting |
| Suwon, Gyeonggi, Korea, Republic of, 433-721 | |
| Contact: Doo-Yeoun Cho, MD +82-31-219-4271 dooycho@ajou.ac.kr | |
| Sub-Investigator: Young-Sang Kim, MD | |
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
| Principal Investigator: | Doo-Yeoun Cho, MD | Ajou University School of Medicine |
More Information
| Responsible Party: | Doo-Yeoun Cho, Assitant Professor, Ajou University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01388660 History of Changes |
| Other Study ID Numbers: | BCA006 |
| Study First Received: | July 5, 2011 |
| Last Updated: | March 25, 2014 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Ajou University School of Medicine:
|
Healthy Platelet Aggregation Inhibitors Pharmacokinetics |
Additional relevant MeSH terms:
|
Platelet Aggregation Inhibitors Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Ticlopidine Clopidogrel 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 Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |
ClinicalTrials.gov processed this record on September 30, 2016