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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2020-02-14

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1

17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8

Group Type EXPERIMENTAL

YHP1807 Tab. 2.5mg

Intervention Type DRUG

Rivaroxaban 2.5mg

YHR1901 Tab. 2.5mg

Intervention Type DRUG

Rivaroxaban 2.5mg

Group2

17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8

Group Type ACTIVE_COMPARATOR

YHP1807 Tab. 2.5mg

Intervention Type DRUG

Rivaroxaban 2.5mg

YHR1901 Tab. 2.5mg

Intervention Type DRUG

Rivaroxaban 2.5mg

Interventions

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YHP1807 Tab. 2.5mg

Rivaroxaban 2.5mg

Intervention Type DRUG

YHR1901 Tab. 2.5mg

Rivaroxaban 2.5mg

Intervention Type DRUG

Other Intervention Names

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Experimental Active comparator

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes