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

Primary Purpose

Prostatic Hyperplasia

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Test formulation

Reference formulation

About this trial

This is an interventional other trial for Prostatic Hyperplasia focused on measuring Bioequivalence, Tamsulosin, Healthy volunteers, Fast conditions

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

tamsulosin Reference

tamsulosin Test

Arm Description

Reference drug administration followed by Test drug administration

Test drug administration followed by Reference drug administration

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01262989

First Posted

September 3, 2010

Last Updated

July 5, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01262989

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 4, 2010 (Actual)

Primary Completion Date

January 26, 2010 (Actual)

Study Completion Date

January 26, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia

Keywords

Bioequivalence, Tamsulosin, Healthy volunteers, Fast conditions

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tamsulosin Reference

Arm Type

Active Comparator

Arm Description

Reference drug administration followed by Test drug administration

Arm Title

tamsulosin Test

Arm Type

Active Comparator

Arm Description

Test drug administration followed by Reference drug administration

Intervention Type

Drug

Intervention Name(s)

Test formulation

Intervention Description

tamsulosin hydrochloride 0,4 mg (Synthon BV)

Intervention Type

Drug

Intervention Name(s)

Reference formulation

Intervention Description

tamsulosin 0,4 mg (Boehringer Ingelheim)

Primary Outcome Measure Information:

Title

AUC0-t

Description

Time Frame

Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)

Title

AUC0-infinity

Description

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.

Time Frame

Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)

Title

Cmax

Description

Time Frame

Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Campinas

State/Province

São Paulo

Country

Brazil

12. IPD Sharing Statement

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

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