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

NCT01262989 | Completed Phase 1 Results

• 1 other identifier: 114071
• Study Type: interventional
• Target: 40
• 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 healthy male volunteers under fasting conditions receive, in each period, the test formulation or the reference formulation

Conditions

Prostatic Hyperplasia

Keywords

Bioequivalence; Tamsulosin; Healthy volunteers; Fast conditions

Outcome Measures

Primary Outcomes (3)

• 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.

  Days 1 to 3 (Period 1) and Days 9 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.

  Days 1 to 3 (Period 1) and Days 9 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 bioavailability of drugs, by measuring the total amount of drug absorbed.

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

Study Arms (2)

tamsulosin Reference

ACTIVE COMPARATOR

Reference drug administration followed by Test drug administration

Drug: Test formulation; Drug: Reference formulation

tamsulosin Test

ACTIVE COMPARATOR

Test drug administration followed by Reference drug administration

Drug: Test formulation; Drug: Reference formulation

Interventions

Test formulation DRUG

tamsulosin hydrochloride 0,4 mg (Synthon BV)

tamsulosin Reference; tamsulosin Test

Reference formulation DRUG

tamsulosin 0,4 mg (Boehringer Ingelheim)

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:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Campinas, São Paulo, Brazil

Location

Related Links

• Results for study 114071 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: September 3, 2010
• First Posted: December 20, 2010
• Study Start: January 4, 2010
• Primary Completion: January 26, 2010
• Study Completion: January 26, 2010
• Last Updated: August 14, 2017
• Results First Posted: March 31, 2011

Record last verified: 2017-07

Locations

BR (1)