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COMPLETED
NCT07807488
PHASE1

Bioequivalence Study of Rivaroxaban 2.5 mg Tablets Under Fasting and Fed Conditions

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

This completed study compared how the body absorbed a single 2.5 mg dose of a test rivaroxaban tablet and the reference product (Xarelto) in healthy adults. The comparison was conducted separately under fasting and fed conditions. The study also evaluated the safety and tolerability of both products.

Official title: A Single-Center, Randomized, Open-Label, Single-Dose, Four-Period, Two-Sequence, Fully Replicated Crossover Bioequivalence Study of Rivaroxaban 2.5 mg Tablets in Healthy Adult Participants Under Fasting and Fed Conditions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2022-03-16

Completion Date

2022-04-25

Last Updated

2026-09-08

Healthy Volunteers

Yes

Interventions

DRUG

Rivaroxaban 2.5 mg Test Tablet

One 2.5 mg rivaroxaban tablet manufactured by Qilu Pharmaceutical Co., Ltd. was administered orally with 240 mL of water in the assigned study periods.

DRUG

Rivaroxaban 2.5 mg Reference Tablet

One 2.5 mg Xarelto rivaroxaban tablet manufactured by Bayer Pharma AG was administered orally with 240 mL of water in the assigned study periods.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China