other thrombophilia. Other thrombophilia
Conditions
Interventions
Intervention 1: Intervention group 1:Apixaban 5 mg Tablet , produced by Actoverco. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wa
Sponsors
Actover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of the normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, and laboratory evaluations Subjects with normal vital signs PT (prothrombin time) and aPTT (activated partial prothrombin time) within the normal range Subjects who agree with a patient consent form
Exclusion criteria
Exclusion criteria: Subjects with known allergies to the products tested Creatinine Clearance (CrCl) of more than 50 Consumption of caffeine-containing products from 24 hours before dosing till 24 hours after its administration Any clinically significant illness during the 4 weeks prior to the first study drug administration Hypotension (systolic blood pressure =100 mmHg or diastolic blood pressure =65 mmHg) or hypertension (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg) Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period Recent use of concomitant medication (prescription or over-the-counter) that could increase the risk of bleeding, or influence apixaban pharmacokinetics History of alcohol or drug abuse Heavy drinkers of caffeine, grapefruit juice, or caffeinated drinks or who are on a special diet (such as vegetarians) or do exertional physical activity A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24 and 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24 and 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Aghaei
Noor Research & Development Institute
Outcome results
None listed