Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316336
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Multiple Dose Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions
Sponsor:
Pharma Nueva
Organization:
Pharma Nueva
Study Overview
Official Title:
An Open-label Randomized Multiple Dose Two-way Crossover Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Reference Product Xatral XL 10 mg in Healthy Thai Male Volunteers Under Fed Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BE24-005
Brief Summary:
Objectives
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulations
Study Design
An open label randomized two-treatment two-period two-sequence multiple oral dose crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulations
Study Design
An open label randomized two-treatment two-period two-sequence multiple oral dose crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2
Detailed Description:
Each subject will receive a single dose of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets as a test formulation T or a single dose of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Xatral XL 10 mg as a reference formulation R with 2402 mL of ambient temperature drinking water at 30 minutes after the start of standardized HFHC breakfast Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the tablet This activity will be followed by a mouth check using a tongue depressor and a flashlight to assess the compliance of dosing The formulations will be given in a crossover fashion as per the randomization schedule The dosing processes will be conducted under normal light condition
In each period total of 21 blood samples will be collected from 21 sampling time points Blood samples 6 mL each will be collected as per the following schedule
Pre-dose blood sample collection Day 1 Day 4 Day 5 and Day 6 Total of 4 pre-dose blood samples 6 mL each will be collected from 4 pre-dose sampling time points on Day 1 Day 4 Day 5 and Day 6
Post-dose blood sample collection Day 6 and Day 7 Total of 17 post-dose blood samples 6 mL each will be collected from 17 post-dose sampling time points at 050 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1600 and 2400 hours post-dose
In each period total of 21 blood samples will be collected from 21 sampling time points Blood samples 6 mL each will be collected as per the following schedule
Pre-dose blood sample collection Day 1 Day 4 Day 5 and Day 6 Total of 4 pre-dose blood samples 6 mL each will be collected from 4 pre-dose sampling time points on Day 1 Day 4 Day 5 and Day 6
Post-dose blood sample collection Day 6 and Day 7 Total of 17 post-dose blood samples 6 mL each will be collected from 17 post-dose sampling time points at 050 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1600 and 2400 hours post-dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None