Last updated: 11/03/2018 16:13:09
SECOTEX® (tamsulosin hydrochloride) Bioequivalence Study Brazil - Fed Admin
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
AUC 0-t
Timeframe: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)
AUC0-infinity
Timeframe: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)
Cmax
Timeframe: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)
Secondary outcomes:
Not applicable
Interventions:
Drug: Reference formulation
Drug: Test formulation
Enrollment:
37
Observational study model:
Not applicable
Primary completion date:
2009-22-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
tamsulosin
Collaborators
Not applicable
Study date(s)
December 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- EXCLUSION CRITERIA:
- The volunteer has a known hypersensitivity to the study drug (tamsulosin hydrochloride) or to compounds chemically related;
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-22-12
Actual study completion date
2009-22-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 114073 can be found on the GSK Clinical Study Register.
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