Bioequivalence Study Healthy Thai Volunteers Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
Conditions
Interventions
Apixaban 5 mg Film-coated tablets, EliquisTM, Reg. No. 1C 4/59 (N), manufactured by PFIZER IRELAND PHARMACEUTICALS, NEWBRIDGE, Ireland, Packed and Released by PFIZER MANUFACTURING DEUTSCHLAND GMBH, FR
Active Comparator Drug,Experimental Drug
Eliquis,Generic Apixaban 5 mg Film-coated tablets,
Sponsors
International Bio Srrvice 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 18.0 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 methods 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 7 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. 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 2. 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 apixaban 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. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical 3.Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4.History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period 5.History or evidence of clinically significant active bleeding 6.Have abnormality of prothrombin time (PT) and activated partial thromboplastin time (aPTT) 7.History or evidence of hepatic disease associated with coagulopathy and clinically relevant bleeding risk 8.Has 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. Has 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. 9.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 10.History of problems with swallowing tablet or capsule 11.History of sensitivity to heparin or heparin-induced thrombocytopenia 12.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 13.History of diarrhea or vomiting within 24 hours prior to check-in in each period 14.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 15.12 lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject eligibility 16Investigation with blood sample shows positive test for HBsAg. 17.Abnormal liver function, more than or equal 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 18.Have renal creatinine clearance (CrCl) <50 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test 19.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apixaban concentrations 0-48 hrs Cmax, AUC0-tlast, AUC0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Apixaban concentrations 0-48 hrs Tmax, T half life , AUC0-tlast/AUC0-infinity | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co.,Ltd.
Outcome results
None listed