Status:
TERMINATED
Comparative Bioavailability Study of Two Oral Formulations of Clopidogrel
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Comparative Bioavailability of Clopidogrel Tablets
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet activation, is widely used to prevent and reduce the risk of thrombotic events. Objective: the aim of the present ...
Detailed Description
Study procedure In each period, the subjects arrived at the clinical/unit site on the day before the commencement of the study and were randomized using Excel® 2007 to receive the test formulation fol...
Eligibility Criteria
Inclusion
- Male or female and age is between 18 and 40 years, inclusive.
- Females must have negative results for pregnancy tests performed:at Screening on a urine specimen obtained within 2 weeks prior to initial study drug administration, and prior to dosing on urine sample obtained on Study Day -1 of each period
- Body Mass Index (BMI) is 19 to 26, inclusive. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion
- History of significant sensitivity to any drug.
- Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, on a regular basis.
- Use of any medications, vitamins and/or herbal supplements, within the 1-week period prior to study drug administration.
- Pregnant or breastfeeding female.
- Recent (6-month) history of drug or alcohol abuse.
- Positive test result for hepatitis B surface antigen (HBsAg) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
- Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., carbamazepine) of cytochrome P450 3A (CYP3A) within 1 month prior to study drug administration.
- Positive screen for drugs of abuse, or alcohol or nicotine or positive and clinically significant urine adulterants test.
- Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
- Receipt of any investigational product within 8 weeks prior to study drug administration or 7 half-lives, whichever is longer.
- Consumption of alcohol within the 3-day period prior to study drug administration.
- Consumption of grapefruit or grapefruit products, Seville oranges, star fruit and quinine/tonic water from 3 days prior to study drug administration.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
- Consideration by the investigator, for an reason, that the subject is an unsuitable candidate to receive Ibuprofen
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01447563
Start Date
May 1 2008
End Date
August 1 2008
Last Update
October 6 2011
Active Locations (1)
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1
Departamento de Farmacologia y Toxicologia
Monterrey, Nuevo León, Mexico, 64460