A bioequivalence study of Rivaroxaban 20 mg tab compared to Xarelto 20 mg tab manufactured by Bayer in 24 healthy volunteers under fasting condition

A cross over bioequivalence study of Rivaroxaban 20 mg tab compared to Xarelto 20 mg tab manufactured by Bayer 24 healthy volunteers under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220209053979N1

Enrollment

Registered

2022-06-24

Start date

2022-07-21

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

Investigation of bioequivalence of Rivaroxaban tablets manufactured by Pars Daroo company in comparison to the xarelto made by Bayer company.

Interventions

Intervention group: Plasma concentration of test and reference drug, and area below concentration-time curve of test and reference drug.

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Have no history of heart, liver, kidney, lung, coagulation disorders They have not taken any medication at least one month before starting the study

Exclusion criteria

Exclusion criteria: Systolic blood pressure above 13 and below 10 and diastolic blood pressure below 6 and above 85 mm Hg heart rate more than 90 or less than 60 beats per minute

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug obtained from rivaroxaban tablets made by Pars Darou Company and Bayer Company. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32 hour. Method of measurement: LCMSMS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Talari

Kharazmi Plasma Center

talari_r@yahoo.com+98 21 5669 4726

Outcome results

None listed

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