Comparative assessment of the absorption of a generic formulation of tamsulosin tablet against the innovator tamsulosin tablet conducted under fasting condition and at steady state in healthy male and female volunteers.
- Conditions
- Tamsulosin is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).Renal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12618001147279
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 30
Normal QTc for males and females
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Concomitant drug therapy of any kind
Any history of orthostatic hypotension.
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the bioavailability of tamsulosin (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for tamsulosin using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[Pre-dose on days 1-4 and 15-18 then on study days 5 and 19 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 hours post dosing]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax). Tmax will be the time where the maximum concentration occurred in the sample points. All plasma samples will be assayed for tamsulosin using a fully validated LC/MS/MS method.[Pre-dose on days 1-4 and 15-18 then on study days 5 and 19 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 hours post dosing]