Status:
COMPLETED
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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...
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 hydr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01262989
Start Date
January 4 2010
End Date
January 26 2010
Last Update
August 14 2017
Active Locations (1)
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1
GSK Investigational Site
Campinas, São Paulo, Brazil