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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: YHR1901 Tab. 2.5mg; Drug: YHP1807 Tab. 2.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05418803

YHP1807-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group1

Experimental group

Description:

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

Treatment:

Drug: YHP1807 Tab. 2.5mg

Drug: YHR1901 Tab. 2.5mg

Group2

Active Comparator group

Description:

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

Treatment:

Drug: YHP1807 Tab. 2.5mg

Drug: YHR1901 Tab. 2.5mg