SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin

Study Overview
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Brief Summary
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It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation or the reference formulation

Detailed Description
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TITLE: Randomized, two-period, cross-over, bioequivalence study on tamsulosin hydrochloride 0,4 mg prolonged release hard gelatin capsule (Synthon BV, The Netherlands) versus SECOTEX® (tamsulosin hydrochloride) 0,4 mg prolonged release hard gelatin capsule (Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda) in healthy male volunteers under fasting conditions. It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation or the reference formulation. The treatment's sequence attributed to each volunteer on the study period is determined by a randomization list, which is generated by PROC PLAN from SAS version 9.1.3 system. The formulations will be administered as a single oral dose followed by blood collections between, at least, 3 to 5 half-lives. The treatment's periods may obey a minimum interval of 7 half lives between them (period for drug's whole elimination by the organism).

Official Title
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Randomized, Two-period, Cross-over, Bioequivalence Study on Tamsulosin Hydrochloride 0,4 mg Prolonged Release Hard Gelatin Capsule Versus SECOTEX® (Tamsulosin Hydrochloride) 0,4 mg Prolonged Release Hard Gelatin Capsule (Boehringer Ingelheim) in Healthy Male Volunteers Under Fasting Conditions.

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Test formulation
* Drug: Reference formulation


Participation Criteria
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Eligibility Criteria
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EXCLUSION CRITERIA: 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 Hypotension or hypertension of any etiologic that needs pharmacologic treatment Volunteer 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 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 consumed inductive drugs and/or enzymatic inhibitors (CYP450 - hepatic), within the 04 weeks that preceded the study's initiation Hospitalization for any reason within 08 weeks of beginning of the study's first period of treatment and the post study assessment date Participation in any experimental study or ingested any experimental drug within the 06 previous months Donation or lost of 450mL or more of blood within the 03 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tamsulosin Reference<br>Reference drug administration followed by Test drug administration | Drug: Test formulation<br>* tamsulosin hydrochloride 0,4 mg (Synthon BV)<br>Drug: Reference formulation<br>* tamsulosin 0,4 mg (Boehringer Ingelheim)<br>|
| Active Comparator: tamsulosin Test<br>Test drug administration followed by Reference drug administration | Drug: Test formulation<br>* tamsulosin hydrochloride 0,4 mg (Synthon BV)<br>Drug: Reference formulation<br>* tamsulosin 0,4 mg (Boehringer Ingelheim)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter. | Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2) | 
| AUC0-infinity | The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. | Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2) | 
| Cmax | Cmax is defined as the maximum or peak concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed. | Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Tamsulosin, Healthy volunteers, Fast conditions