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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330303
First Posted: April 6, 2011
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Prostatic Hyperplasia Drug: Reference formulation Drug: Test formulation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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 Healthy Male Volunteers Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC 0-t [ Time Frame: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 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: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 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: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 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 the bioavailability of drugs, by measuring the total amount of drug absorbed.


Enrollment: 37
Actual Study Start Date: December 8, 2009
Study Completion Date: December 22, 2009
Primary Completion Date: December 22, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tamsulosin - Reference
Reference drug administration followed by Test drug administration
Drug: Reference formulation
SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)
Drug: Test formulation
tamsulosin hydrochloride 0,4 mg (Synthon BV)
Active Comparator: tamsulosin - Test
Test drug administration followed by Reference drug administration
Drug: Reference formulation
SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)
Drug: Test formulation
tamsulosin hydrochloride 0,4 mg (Synthon BV)

Detailed Description:

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.

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330303


Locations
Brazil
GSK Investigational Site
Campinas, São Paulo, Brazil
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01330303     History of Changes
Other Study ID Numbers: 114073
First Submitted: August 30, 2010
First Posted: April 6, 2011
Results First Submitted: March 10, 2011
Results First Posted: April 6, 2011
Last Update Posted: August 1, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Bioequivalence
Healthy volunteers
tamsulosin hydrochloride
Fed administration

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents