Healthy volunteer Clopidogrel, Bioequivalence Study, Healthy Thai Volunteer
Conditions
Interventions
Clopidogrel 75 mg film-coated tablet (Test product)
Each tablet contains clopidogrel 75 mg,Clopidogrel 75 mg film-coated tablet (Reference product)
Each tablet contains clopidogrel 75 mg
Experimental Drug,Active Comparator Drug
Clopidogrel 75 mg,Plavix 75 mg
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male or female subjects between the ages of 18 to 55 years. 2. Body mass index between 18.5 to 30.0 kg/m2. 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5. Female subjects abstain from either hormonal method of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 4. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months. 6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 4. 7. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to clopidogrel or to another thienopyridine (such as ticlopidine, prasugrel) or to any of the excipients. 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. 3. History or evidence of active clinically significant bleeding e.g. intracranial or intracerebral bleeding, gastrointestinal bleeding. 4. History or evidence of hepatic disease associated with coagulopathy and clinically relevant bleeding risk. 5. Have lesion or condition if considered a significant risk factor for major bleeding including current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. 6. History or evidence of anaemia or neutropenia or thrombocytopenia. 7. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 8. History of problems with swallowing tablet or capsule. 9. History of sensitivity to heparin or heparin-induced thrombocytopenia. 10. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy. 11. History of diarrhea or vomiting within 24 hours prior to check-in in each period. 12. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). 13. Investigation with blood sample shows positive test for HBsAg. 14. Abnormal liver function, >=1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. 15. Have eGFR (CKD-EPI) <=90 mL/min/1.73 m2 based on serum creatinine results at the screening laboratory test or during enrollment. 16. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study. 17. History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.). 18. History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result. In case of alcohol breath test result represents the alcohol concentration range of 1-10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma clopidogrel concentrations 0.00-36.00 hours post-dose Maximum observed plasma concentration (Cmax), Area under the plasma concentration-time curve from zero to last measurable concentration (AUC0-tlast) and from zero extrapolated to infinity (AUC0-inf) | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma clopidogrel concentrations 0.00-36.00 hours post-dose Time to reach maximum observed plasma concentration (Tmax), Elimination half-life (t1/2), Elimination rate constant (Kel) and Mean residence time (MRT) | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed