Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets
Status:
COMPLETED
Trial end date:
2023-08-29
Target enrollment:
Participant gender:
Summary
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fasting conditions which included 28 healthy adult male and female subjects. The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 10 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 10 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fasting condition in healthy subjects.