NCT06558045

Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets

Bioequivalence Study of Rivaroxaban 20 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Xarelto® 20 mg Film-Coated Tablet, Manufactured by Bayer AG, Germany, Imported by PT Bayer Indonesia, Indonesia) When Administered Under Fed Condition in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed 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 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects.

Detailed description

The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects. This was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The participating subjects were given orally the test drug (rivaroxaban 20 mg film-coated tablet produced by PT Dexa Medica) or the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) with total 200 mL of water 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. Subjects had to ingest meal within 30 minutes or less. Start and end of breakfast were documented. The subject's oral cavity was checked thoroughly to confirm complete medication and fluid consumption after dosing. Blood samples were drawn before taking the drug (control), and at 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.00, 24.00 and 36.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of rivaroxaban following single dose administration. The plasma concentrations of rivaroxaban were determined by using a validated ultra-performance liquid chromatography with tandem mass spectrometry detection (UPLC-MS/MS).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rivaroxaban 20 mg film-coated tablet	One tablet of the test drug was given orally 30 minutes after subjects have consumed a standardized high fat meal as breakfast
DRUG	Xarelto 20 mg film-coated tablet	One tablet of the reference drug was given orally 30 minutes after subjects have consumed a standardized high fat meal as breakfast

Timeline

• Start date: 2023-07-06
• Primary completion: 2023-07-18
• Completion: 2023-10-02
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: Indonesia