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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05418803

Enrollment

Registered

2022-06-14

Start date

2020-01-28

Completion date

2020-02-14

Last updated

2022-06-16

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

Conditions

Healthy Volunteer

Brief 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.

Interventions

DRUGYHP1807 Tab. 2.5mg

Rivaroxaban 2.5mg

DRUGYHR1901 Tab. 2.5mg

Rivaroxaban 2.5mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
AUCt	0-36 hours	AUCt of Rivaroxaban
Cmax	0-36 hours	Cmax of Rivaroxaban

Secondary

Measure	Time frame	Description
AUCinf	0-36 hours	AUCinf of Rivaroxaban
Tmax	0-36 hours	Tmax of Rivaroxaban
t1/2	0-36 hours	t1/2 of Rivaroxaban

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026