Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions
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.
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 240±2 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 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00 and 24.00 hours post-dose.
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