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

NCT01330303 | Completed Phase 1 Results

• 1 other identifier: 114073
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia

Keywords

Bioequivalence; Healthy volunteers; tamsulosin hydrochloride; Fed administration

Outcome Measures

Primary Outcomes (3)

• 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.

  Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)

• 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.

  Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)

• 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.

  Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)

Study Arms (2)

tamsulosin - Reference

ACTIVE COMPARATOR

Reference drug administration followed by Test drug administration

Drug: Reference formulation; Drug: Test formulation

tamsulosin - Test

ACTIVE COMPARATOR

Test drug administration followed by Reference drug administration

Drug: Reference formulation; Drug: Test formulation

Interventions

Reference formulation DRUG

SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)

tamsulosin - Reference; tamsulosin - Test

Test formulation DRUG

tamsulosin hydrochloride 0,4 mg (Synthon BV)

tamsulosin - Reference; tamsulosin - Test

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• Male;
• Age between 18 and 50 years;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Campinas, São Paulo, Brazil

Location

Related Links

• Results for study 114073 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: April 6, 2011
• Study Start: December 8, 2009
• Primary Completion: December 22, 2009
• Study Completion: December 22, 2009
• Last Updated: August 1, 2017
• Results First Posted: April 6, 2011

Record last verified: 2017-06

Locations

BR (1)