Comparative in vivo evaluation of 2 Ticagrelor 90 mg F.C. Tablet and Brilinta® 90 mg F.C. Tablet formulations.

Not Applicable

Conditions: ong term (current) use of antithrombotics/antiplatelets.
Long term (current) use of antithrombotics/antiplatelets
Z79.02

Registration Number: IRCT20180620040164N54

Lead Sponsor: Zist Arvand Pharme Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Male

Target Recruitment: 24

Inclusion Criteria

Healthy subjects (male) between 18 – 45 years of age.
Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 and 27 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or abnormal findings during laboratory evaluations and clinical examination.
Subjects with normal vital signs.

Exclusion Criteria

Subjects with known allergy to the products tested.
volunteers with associated acute or chronic infections.
Personal history of vascular abnormality such as aneurysm, thrombocytopenia, peptic ulcer and platelet count less than 109*150/liter.
heart rate less than 60 per minute.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
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 Timepoint: 18 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after intervention.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 Timepoint: 18 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after intervention.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).