Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets Under Fasted Conditions
|ClinicalTrials.gov Identifier: NCT01418586|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Primary objective of the present study was to assess the relative bioavailability of two formulations of Extended Release Alfuzosin 10 mg under Fasted conditions, in healthy adult male subjects after an oral administration with 7 days washout period.
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Alfuzosin Extended Release Tablet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets vs. Sanofi's Uroxatral ER Tablets in Healthy Human Subjects Under Fasted Conditions|
- bioequivalence based on Composite of Pharmacokineticsbioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418586
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India, 382428|