SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Reference formulation; Test formulation
Intervention description: SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim); tamsulosin hydrochloride 0,4 mg (Synthon BV)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy volunteers; tamsulosin hydrochloride; Fed administration

Summary:

      It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,
      02 sequences, and 02 periods, in which the volunteers receive, in each period, the test
      formulation or the reference formulation, under fed conditions.
    

Eligibility criteria:

        EXCLUSION CRITERIA:

          -  The volunteer has a known hypersensitivity to the study drug (tamsulosin
             hydrochloride) or to compounds chemically related;

          -  History or presence of hepatic or gastrointestinal illnesses, or other condition that
             interferes over the drug's absorption, distribution, excretion or metabolism;

          -  History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or
             psychiatric illness; hypo or hypertension of any etiologic that needs pharmacologic
             treatment; has history or had myocardial infarction, angina and/or heart
             insufficiency;

          -  Non-recommended electrocardiographic findings, according investigator criteria;

          -  The results of the laboratory exams are out of the values considered as normal
             according this protocol's rules, unless that they are considered as clinically
             irrelevant by the investigator;

          -  Volunteer is a smoker;

          -  The volunteer ingests more than 5 cups of coffee or tea a day;

          -  Has history of alcohol or drugs abuse;

          -  History of serious adverse reactions or hypersensitivity to any drug;

          -  Use of any regular drug within the 02 weeks that preceded study's initiation or
             treatment within the 03 previous months, that preceded study's initiation, with any
             drug that presents toxic, or volunteer consumed inductive drugs and/or enzymatic
             inhibitor (CYP450 - hepatic), within the 04 weeks that preceded the study's
             initiation;

          -  Volunteer was hospitalized for any reason within the 08 weeks of the beginning of the
             study's first period of treatment and the post study assessment date;

          -  Participation in any experimental study or ingestion of any experimental drug within
             the 06 previous months;

          -  Volunteer consumed alcohol in 48 hours prior to the admission to the study or consumed
             foods or beverages that contain grapefruit until 07 days previous to each study
             period.

        INCLUSION CRITERIA:

          -  Male;

          -  Age between 18 and 50 years;

          -  Body mass index ≥ 19 and ≤28,5;

          -  Good health conditions or without significant illness, by judgment of a legally
             qualified professional, according the rules defined in Protocol, and according the
             following evaluations: clinical history, pressure and pulse measures, physical and
             psychological exam, ECG, and additional laboratory exams;

          -  Capable to understand the study's nature and aim, including the risks and adverse
             effects and with intention to cooperate with the researcher and to act in compliance
             with the requirements of the whole assay; this will be confirmed by the Informed
             Consent's signature.