The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands), after single dose administration in healthy adult male subjects under fasting conditions.
Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Healthy male subjects aged 18 to 45 years inclusive, at the time of signing the ICF, able to tolerate venipuncture.
Verified diagnosis of being "healthy" according to results of standard clinical, laboratory and instrumental methods of examination.
Body weight ≥50 kg and ≤ 120 kg, Body Mass Index between ≥18.5 and ≤30.0 kg/m2.
History or presence of allergies.
Known hypersensitivity or intolerance to tamsulosin and/or other alpha 1 adreno-receptor antagonists and/or any other excipient of the study drugs.
History of drug-induced angioedema.
History, presence or necessity of glaucoma or cataract surgery.
Crossover
Tamsulosin (0.4 mg/j)
DrugProlonged-release tablets 0.4 mg (Synthon Hispania SL, Spain)
Tamsulosin (0.4 mg/j)
DrugProlonged-release, film-coated tablets (Astellas Pharma B.V., the Netherlands)
Cmax
Maximum plasma concentration
AUC 0-t
Area under the Plasma Concentration Curve from Administration to Last Observed Concentration at Time t
AUC 0-inf
Area under the Plasma Concentration Curve Extrapolated to Infinite Time
Tmax
Time to maximum plasma concentration
t 1/2
Plasma half-life
λz
Terminal Elimination Rate Constant
AUC Resid
Residual area
Analysis of Adverse Events (AEs)
Number (%) of subjects with any AE
Analysis of Adverse Events (AEs)
Number (%) of subjects with treatment-related AEs
Analysis of Adverse Events (AEs)
Number (%) of subjects with any Serious Adverse Events (SAEs)
Analysis of Adverse Events (AEs)
Number (%) of subjects with treatment-related SAEs
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