KCT0000412Recruiting未知
A Randomized, Open-label, Single dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Pharmacokinetics of a Clopidogrel and Aspirin combination capsule Compared with a Clopidogrel Tablet and Aspirin capsule under Fasted Conditions in Healthy Male Subjects
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Ildong pharmaceutical
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 55(Year) (—)
- Sex
- Male
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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