Comparative in vivo evaluation of 2 ?Apixaban 5 mg Tablet formulations.

Not Applicable

• Conditions: other thrombophilia.; Other thrombophilia; D68.6

• Registration Number: IRCT20180620040164N37
• Lead Sponsor: Actover Pharmaceutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 24

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Timepoint: 16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24 and 48 hours after intervention.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 Outcome Measures

Name	Time	Method
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).