A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Randomized, Repeat Dose, 3 Period Cross Over Study to Determine the Bioequivalence of 3 Different Formulations of Tamsulosin at Steady State in Healthy Male Volunteers|
- PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72
- Clinical safety labs [ Time Frame: at check in ]
- measurement of orthostatic hypotension [ Time Frame: at 6 hours post dose on days 1 and 7 ]
- adverse event reporting
- C(tau) (pre-dose concentrations determined immediately before a dose at steady state), t1/2, tmax, lambda, Cmin and fluctuation [(Cmax - Cmin)/(AUC(0-24)/24)] of tamsulosin, as data permit.
- Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, adverse events and clinical laboratory safety tests.
|Study Start Date:||February 2008|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|