NCT06817811

Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet

Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Eliquis® 5 mg Film Coated Tablet, Bristol-Myers Squibb Company, Puerto Rico, Packed and Released By Bristol-Myers Squibb S.R.L., Italy, Imported by PT Pfizer Indonesia)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects. The objective of this study was to find out whether the bioavailability of apixaban 5 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Eliquis® 5 mg filmcoated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia).

Detailed description

The objective of this study was to find out whether the bioavailability of apixaban 5 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Eliquis® 5 mg filmcoated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia). This was an open-label, randomized, single dose, two-period, two-sequence, cross-over study under fasting condition which included 24 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 (apixaban 5 mg film-coated tablet produced by PT Dexa Medica) or the comparator drug (Eliquis® 5 mg Film Coated Tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia) with 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 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 9.00, 12.00, 24.00, 36.00, and 48.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of apixaban following single dose administration. The plasma concentrations of apixaban were determined by using a validated ultra-performance liquid chromatography with tandem mass spectrometry detection (UPLC-MS/MS).

Conditions

• Health

Interventions

Type	Name	Description
DRUG	Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)	One tablet of the test drug was given orally under fasting condition
DRUG	Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)	One tablet of the reference drug was given orally under fasting condition

Timeline

• Start date: 2021-04-15
• Primary completion: 2021-04-24
• Completion: 2021-06-03
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: Indonesia