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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: YHP1807 Tab. 2.5mg; Drug: YHR1901 Tab. 2.5mg

• Registration Number: NCT05418803
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study Start: 2020-01-28
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-13
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group1	YHP1807 Tab. 2.5mg	17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8
Group2	YHP1807 Tab. 2.5mg	17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8
Group2	YHR1901 Tab. 2.5mg	17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8
Group1	YHR1901 Tab. 2.5mg	17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8

Primary Outcome Measures

Name	Time	Method
AUCt	0-36 hours	AUCt of Rivaroxaban
Cmax	0-36 hours	Cmax of Rivaroxaban

Secondary Outcome Measures

Name	Time	Method
t1/2	0-36 hours	t1/2 of Rivaroxaban
AUCinf	0-36 hours	AUCinf of Rivaroxaban
Tmax	0-36 hours	Tmax of Rivaroxaban

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of