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

• Status: Completed
• Trial end date: 2020-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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.