Relative bioavailability of clopidogrel 75mg from two tablet formulations of SB224326 relative to one 75mg reference tablet of clopidogrel in healthy adult human subjects under fasting conditions
- Registration Number
- CTRI/2016/04/006789
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Adult subjects aged between 18 and 65 years of age inclusive at the time of signing the informed consent.
Healthy non-smoker as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >=50 kilograms (kg) and Body mass index (BMI) within the range 19 â?? 24.9 kg/square meter kg/m2 (inclusive)
Sex
•Male
•Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies.
Non-reproductive potential defined as
•Pre-menopausal females with one of the following
•Documented tubal ligation
•Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
•Hysterectomy
•Documented bilateral oophorectomy
•Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment
•Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until [at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer] after the last dose of study medication and completion of the follow-up visit.INFORMED CONSENT
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Plavix contains lactose and subjects with lactose intolerance should not be included.
The QTc is the QT interval corrected for heart rate according to Bazettâ??s formula (QTcB), Fridericiaâ??s formula (QTcF), and/or another method, machineread or manually over-read
The following medications increase risk of bleeding: Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs).
•History of sensitivity to heparin or heparin-induced thrombocytopenia
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the relative bioavailability (BA) of clopidogrel following administration of two tablet formulations of clopidogrel (SB224326; 75mg) relative to reference clopidogrel (Plavix; 75mg) in healthy human subjects under fasting conditions.Timepoint: Day 1: pre-dose, 0.25, 0.5, 0.75, 1.00, 1.33, 1.67, 2, 2.5, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 (Day 2) hours post-dose of each treatment period
- Secondary Outcome Measures
Name Time Method Plasma PK parameters: tmax, %AUCex and t½ <br/ ><br> <br/ ><br>To monitor the safety and tolerability following administration of two tablet test formulations of clopidogrel (SB224326; 75mg) compared to reference clopidogrel (Plavix; 75mg) in healthy human subjects under fasting conditions. <br/ ><br> <br/ ><br>Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, review of adverse events and clinical laboratory safety data.Timepoint: Day 1: pre-dose, 0.25, 0.5, 0.75, 1.00, 1.33, 1.67, 2, 2.5, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 (Day 2) hours post-dose of each treatment period