Pharmacokinetic study for fixed-dose combination of clopidogrel and aspirin in healthy volunteers
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0000412
- Lead Sponsor
- Ildong pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 60
1. Healthy male subjects between the ages of 20 and 55 years at screening
2. Subjects with a body weight within ± 20% of their ideal weight and over 55kg
3. Subjects must be in generally good health as determined by pre-study medical history and physical examination, with no congenital or chronic diseases.
4. Subjects must be in generally good health as determined by laboratory tests including blood hematology, biochemistry, blood clotting test, urinalysis, and serologic tests;
5. Subjects must be able to read, understand, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
1. Presence or history of hypersensitivity to clopidogrel, aspirin, or other anti-thrombotic drugs
2. Subjects with systolic blood pressure = 100 mmHg or diastolic blood pressure = 50 mmHg, or systolic blood pressure = 145 mmHg or diastolic blood pressure = 95 mmHg, with pulse rate < 45 bpm or > 100 bpm
3. Subjects with AST or ALT count, the upper limit of reference range in excess of 1.25 times, or total bilirubin, the upper limit of reference range in excess of 1. 5 times, or PT, aPTT, BT exceeded the reference range
4. Subjects with platelet count < 150,000/microL or > 350,000/micro/L
5. Subjects with active bleeding (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, gross hematuria, hemoptysis, vitreous hemorrhage, and so on) or subjects showing bleeding tendency (active peptic ulcer, hemorrhagic stroke within 6 months, surgical interventions within 3 months, proliferative diabetic retinopathy, refractory hypertension, and so on)
6. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic (including bleeding tendency), gastrointestinal, central nervous system, psychiatric, or malignant disease
7. Subjects with atrial and ventricular displacement, atrial fibrillation or flutter, ventricular tachycardia and ventricular fibrillation, or multifocal ventricular ectopic beats, QT interval prolongation
8. A history of gastrointestinal disease (e.g., Crohn’s disease, ulceration) or resection operation (excluding simple appendectomy or herniorrhaphy)
9. Presence or history of peptic ulcer or gastrointestinal hemorrhage within 2 months prior to scheduled study drug administration
10. History of alcohol abuse or excessive smoking, or subjects who are not willing to abstain from drinking or smoking for the duration of study
11. Use of any other investigational drugs within 3 months prior to scheduled study drug administration
12. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration
13. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration
14. Use of any prescription drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to scheduled study drug administration
15. Current or previous abuse of drugs or alcohol
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax of clopidogrel;AUC of clopidogrel;Cmax of acetylsalicylic acid;AUC of acetylsalicylic acid
- Secondary Outcome Measures
Name Time Method tmax of clopidogrel;Half-life of clopidogrel;tmax of acetylsalicylic acid;Half-life of acetylsalicylic acid