Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558045
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Medicas 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 Medicas 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 subjects 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 050 100 133 167 200 233 267 300 333 367 400 433 467 500 550 600 800 1200 2400 and 3600 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-MSMS
Start and end of breakfast were documented The subjects 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 050 100 133 167 200 233 267 300 333 367 400 433 467 500 550 600 800 1200 2400 and 3600 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-MSMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None