Phase 1Completed
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)
- Sponsor
- Dexa Medica Group (Industry)
- Enrolment
- 24 enrolled
- Conditions
- Health
- Interventions
- Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica); 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)
- Ages
- adults
- Registry
- NCT06817811
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- AUC(0-t)
- Cmax
History
Registered
Study completion
Primary completion
Started