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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418803
• Other study ID #: YHP1807-101
• Status: Completed
• Phase: Phase 1
• Start date: January 28, 2020
• Est. completion date: February 14, 2020

Study information

• Verified date: June 2022
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• YHP1807 Tab. 2.5mg
Rivaroxaban 2.5mg
• YHR1901 Tab. 2.5mg
Rivaroxaban 2.5mg

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	AUCt of Rivaroxaban	0-36 hours
Primary	Cmax	Cmax of Rivaroxaban	0-36 hours
Secondary	AUCinf	AUCinf of Rivaroxaban	0-36 hours
Secondary	Tmax	Tmax of Rivaroxaban	0-36 hours
Secondary	t1/2	t1/2 of Rivaroxaban	0-36 hours