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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01262989
First received: September 3, 2010
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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 (Boehringer Ingelheim) in Healthy Male Volunteers Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC0-t [ Time Frame: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2010
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tamsulosin Reference
Reference drug administration followed by Test drug administration
Drug: Test formulation
tamsulosin hydrochloride 0,4 mg (Synthon BV)
Drug: Reference formulation
tamsulosin 0,4 mg (Boehringer Ingelheim)
Active Comparator: tamsulosin Test
Test drug administration followed by Reference drug administration
Drug: Test formulation
tamsulosin hydrochloride 0,4 mg (Synthon BV)
Drug: Reference formulation
tamsulosin 0,4 mg (Boehringer Ingelheim)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262989

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01262989     History of Changes
Other Study ID Numbers: 114071, LOC114071
Study First Received: September 3, 2010
Results First Received: March 3, 2011
Last Updated: April 7, 2011
Health Authority: Brazil: Institutional Review Board
Brazil: ANVISA

Keywords provided by GlaxoSmithKline:
Bioequivalence
Tamsulosin
Healthy volunteers
Fast conditions

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

ClinicalTrials.gov processed this record on July 24, 2014