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

Comparative bioequivalence study of Ticagrelor 90 mg F.C. Tablet of Zist Arvand Pharmed. and Brilinta®of Asterazeneca Sciences as reference in 24 healthy male under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N54

Enrollment

Registered

2024-01-22

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long term (current) use of antithrombotics/antiplatelets. Long term (current) use of antithrombotics/antiplatelets

Interventions

Intervention 1: Intervention group 1 (Test): Ticagrelor 90 mg F.C. Tablet , produced by Zist arvand Pharmed. is the test product. In each period, 12 of 24 subjects will be given single oral dose of th

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 18 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after intervention.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

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Montaha Sangari

Noor Research & Development Institute

Behzad_first@yahoo.com+98 21 6600 4027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026