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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 26, 2010

Detailed Description

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).

Interventions

  • Drug: Test formulation
    • tamsulosin hydrochloride 0,4 mg (Synthon BV)
  • Drug: Reference formulation
    • tamsulosin 0,4 mg (Boehringer Ingelheim)

Arms, Groups and Cohorts

  • Active Comparator: tamsulosin Reference
    • Reference drug administration followed by Test drug administration
  • Active Comparator: tamsulosin Test
    • Test drug administration followed by Reference drug administration

Clinical Trial Outcome Measures

Primary Measures

  • AUC0-t
    • Time Frame: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)
    • 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.
  • AUC0-infinity
    • Time Frame: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)
    • 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.
  • Cmax
    • Time Frame: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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