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

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.

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.