NCT06558058

Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets

Bioequivalence Study of Rivaroxaban 10 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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 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.

Detailed description

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. This 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 participating subjects were required to have an 8 hours overnight fast and in the next morning (first day of period) were given orally the test drug (rivaroxaban 10 mg film-coated tablet produced by PT Dexa Medica) or the comparator drug (Xarelto® 10 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) with total 200 mL of water. 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 0.33, 0.67, 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, 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rivaroxaban 10 mg film-coated tablet	One tablet of the test drug was given orally after an overnight fast.
DRUG	Xarelto 10 mg film-coated tablet	One tablet of the reference drug was given orally after an overnight fast.

Timeline

• Start date: 2023-06-08
• Primary completion: 2023-06-16
• Completion: 2023-08-29
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: Indonesia