The objective of this study is to evaluate the comparative bioavailability between Tamsulosin Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
Test 0.4 mg Capsule
Reference Listed 0.4 mg Capsule
Pharma Medica Research Inc.
Toronto, Ontario, Canada
Cmax (maximum observed concentration of drug substance in plasma)
Bioequivalence based on Cmax
Time frame: Blood samples drawn over 60 hour time period
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Bioequivalence based on AUC0-t
Time frame: Blood samples drawn over 60 hour time period
AUC0-inf (area under the concentration-time curve from time zero to infinity)
Bioequivalence based on AUC0-inf
Time frame: Blood samples drawn over 60 hour time period
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