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

Yuhan Corporation34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

YHP1807 Tab. 2.5mgDRUG

Rivaroxaban 2.5mg

YHR1901 Tab. 2.5mgDRUG

Rivaroxaban 2.5mg

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2 * Acceptable medical history, physical examination, laboratory tests and EKG, during screening * Subjects who has signed a written informed consent voluntarily Exclusion Criteria: * History of clinically significant medical history or current disease * Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg). * AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit * Total bilirubin \> 2.0 mg/dl * Volunteers considered not eligible for the clinical trial by the investigator * Administration of other investigational products within 6 month prior to the first dosing.

Locations (1)

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

AUCt

AUCt of Rivaroxaban

Time frame: 0-36 hours

Cmax

Cmax of Rivaroxaban

Time frame: 0-36 hours

Secondary Outcomes

AUCinf

AUCinf of Rivaroxaban

Time frame: 0-36 hours

Tmax

Tmax of Rivaroxaban

Time frame: 0-36 hours

t1/2

t1/2 of Rivaroxaban

Time frame: 0-36 hours

Data from ClinicalTrials.gov

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