NCT04689919

Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions

A Single Center, Open Label, Randomized, Single-dose, Two Period Two Way Cross-over Study to Explore the Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions in Healthy Male Pakistani Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Karachi · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days. Blood samples will be taken up to 48hours post-dose.

Detailed description

Single oral administrations of study drug in two periods separated by a washout period of 07 days. Subjects will take their assigned study medication orally, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point. Total duration of treatment of study drug will be of 58 hours comprising 10 hours prior drug administration until 48 hours post dose in each study period. Pharmacokinetic parameters include Rivaroxaban plasma concentrations at the given sampling times. In each period 16 blood samples for plasma Rivaroxaban concentrations will be taken on Day 2, Day 3 and Day 4 including 0.00 hour pre dose and post dose at 0.25, 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.5, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00 and 48.00 hours.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Rivaroxaban 20 MG Oral Tablet	The subjects randomly received single oral dose of Rivaroxaban 20 MG Tablet.

Timeline

• Start date: 2022-02-19
• Primary completion: 2022-03-07
• Completion: 2022-04-05
• First posted: 2020-12-30
• Last updated: 2022-09-07

Locations

1 site across 1 country: Pakistan