Back to resultsSECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
Primary Purpose
Prostatic Hyperplasia
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Reference formulation
Test formulation
Sponsored by
About this trial
This is an interventional other trial for Prostatic Hyperplasia focused on measuring Bioequivalence, Healthy volunteers, tamsulosin hydrochloride, Fed administration
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
AUC 0-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 the bioavailability of drugs, by measuring the total amount of drug absorbed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01330303
Brief Title
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed 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 Healthy Male Volunteers Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 8, 2009 (Actual)
Primary Completion Date
December 22, 2009 (Actual)
Study Completion Date
December 22, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
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 volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
Bioequivalence, Healthy volunteers, tamsulosin hydrochloride, Fed administration
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (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)
Reference formulation
Intervention Description
SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)
Intervention Type
Drug
Intervention Name(s)
Test formulation
Intervention Description
tamsulosin hydrochloride 0,4 mg (Synthon BV)
Primary Outcome Measure Information:
Title
AUC 0-t
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 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.
Time Frame
Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 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
Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)
Title
Cmax
Description
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.
Time Frame
Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 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
Accepts Healthy Volunteers
Eligibility 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.
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
Learn more about this trial
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
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