Bioequivalence study of Rivaroxaban 20mg tablet

Bioequivalence study of Rivaroxaban 20mg tablet manufactured by Darou Darman Arang versus originator brand in healthy volunteers in the fasted condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N28

Enrollment

Registered

2023-03-19

Start date

2023-05-05

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: single dose, one oral tablet of Xaltero 20mg manufactured by Bayer, as a reference product. Intervention 2: Intervention group: Single dose, one oral tablet of Alte

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to Rivaroxaban

Design outcomes

Primary

Measure	Time frame
The plasma concentration of the drug. Timepoint: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48 and 72 h after drug admin. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

Ghasemian_elham@yahoo.com+98 23 3522 5046

Outcome results