NCT05418803

BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects

An Open-label, Randomized, 2-sequence, 2-period, Fasted, Single Dose, Oral Administration, Crossover Study to Evaluate the Bioequivalence of YHP1807 Tablets 2.5 mg and YHR1901 Tablets 2.5 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.

Detailed description

This study was a randomized, open-label, single-dose, two-period, crossover study which included 34 healthy adult male and female subjects under fasting conditions. A single dose of experimental drug or comparator was administered in each of the two study periods (separated by a washout period of 1 week). Serial blood samples were collected up to 36 hours post-dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUCt), were determined by non-compartmental analysis. The geometric mean ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax and AUCt were calculated to evaluate pharmacokinetic equivalence.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	YHP1807 Tab. 2.5mg	Rivaroxaban 2.5mg
DRUG	YHR1901 Tab. 2.5mg	Rivaroxaban 2.5mg

Timeline

• Start date: 2020-01-28
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2022-06-14
• Last updated: 2022-06-16

Locations

1 site across 1 country: South Korea