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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: YHP1807 Tab. 2.5mg
* Drug: YHR1901 Tab. 2.5mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br>17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8 | Drug: YHP1807 Tab. 2.5mg<br>* Rivaroxaban 2.5mg<br>* Other names: Experimental;Drug: YHR1901 Tab. 2.5mg<br>* Rivaroxaban 2.5mg<br>* Other names: Active comparator;|
| Active Comparator: Group2<br>17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8 | Drug: YHP1807 Tab. 2.5mg<br>* Rivaroxaban 2.5mg<br>* Other names: Experimental;Drug: YHR1901 Tab. 2.5mg<br>* Rivaroxaban 2.5mg<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | AUCt of Rivaroxaban | 0-36 hours | 
| Cmax | Cmax of Rivaroxaban | 0-36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | AUCinf of Rivaroxaban | 0-36 hours | 
| Tmax | Tmax of Rivaroxaban | 0-36 hours | 
| t1/2 | t1/2 of Rivaroxaban | 0-36 hours |