Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558032
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Bioequivalence Study of Tamsulosin 04 mg Sustained Release Film-coated Tablets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bioequivalence Study of Tamsulosin 04 mg Sustained Release Film Coated Tablet Produced by PT Dexa Medica in Comparison With The Comparator Drug Harnal Ocas 04 mg Prolonged Release Tablet Produced by Astellas Pharma Europe BV The Netherlands Imported by PT Combiphar Indonesia When Administered Under Fasting 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 four-period two-sequence fully replicate study under fasting conditions which included 28 healthy adult male subjects The objective of this study was to find out whether the bioavailability of tamsulosin 04 mg sustained release film coated tablet produced by PT Dexa Medica is equivalent to that of the comparator drug Harnal OCAS 04 mg Prolonged Release Tablet produced by Astellas Pharma Europe BV The Netherlands imported by PT Combiphar Indonesia when administered under fasting condition in healthy subjects
Detailed Description:
The objective of this study was to find out whether the bioavailability of tamsulosin 04 mg sustained release film coated tablet produced by PT Dexa Medica is equivalent to that of the comparator drug Harnal OCAS 04 mg Prolonged Release Tablet produced by Astellas Pharma Europe BV The Netherlands imported by PT Combiphar Indonesia when administered under fasting condition in healthy subjects This was an open-label randomized single-dose four-period two-sequence fully replicate study under fasting conditions which included 28 healthy adult male 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 tamsulosin 04 mg sustained release film coated tablet produced by PT Dexa Medica or the comparator drug Harnal OCAS 04 mg Prolonged Release Tablet produced by Astellas Pharma Europe BV The Netherlands imported by PT Combiphar Indonesia with total 200 mL of water 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 100 200 300 400 500 600 700 800 900 1000 1100 1200 1800 2400 3600 4800 and 7200 hours after drug administration These blood samples were used to investigate the pharmacokinetic parameters of Tamsulosin following single dose administration The plasma concentrations of Tamsulosin were determined by using validated ultra-performance liquid chromatography with tandem mass spectroscopy detection UPLC-MSMS method
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