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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamsulosin - Reference | Active Comparator | Reference drug administration followed by Test drug administration |
|
| tamsulosin - Test | Active Comparator | Test drug administration followed by Reference drug administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference formulation | Drug | SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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EXCLUSION CRITERIA:
INCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Campinas | São Paulo | Brazil |
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| Label | URL |
|---|---|
| Results for study 114073 can be found on the GSK Clinical Study Register. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product in Period 1; Reference Product in Period 2 | Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 |
| FG001 | Reference Product in Period 1; Test Product in Period 2 | Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| 7-Day Washout Period |
| ||||||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Both Test Product and Reference Product | Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 or reference product in Period 1 and test product in Period 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng per hour per ml (ng.h/ml) | Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product in Period 1; Reference Product in Period 2 | Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Ds Navigator | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Test formulation | Drug | tamsulosin hydrochloride 0,4 mg (Synthon BV) |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Reference Product | Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both periods |
|
|
|
| Primary | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng.h/ml | Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2) |
|
|
|
|
| Primary | 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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng/ml | Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2) |
|
|
|
|
| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Reference Product in Period 1; Test Product in Period 2 | Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2 | 0 | 20 | 8 | 20 |
| Vomiting | Gastrointestinal disorders | Ds Navigator | Systematic Assessment |
|
| Serum glutamic-pyruvic increased | Investigations | Ds Navigator | Systematic Assessment |
|
| Gamma glutamyl transferase increased | Investigations | Ds Navigator | Systematic Assessment |
|
| Glucose high | Investigations | Ds Navigator | Systematic Assessment |
|
| Serum triglycerides increased | Investigations | Ds Navigator | Systematic Assessment |
|
| Serum urea increased | Investigations | Ds Navigator | Systematic Assessment |
|
| Serum bilirubin increased (total and indirect) | Investigations | Ds Navigator | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Ds Navigator | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Ds Navigator | Systematic Assessment |
|
| Headache | Nervous system disorders | Ds Navigator | Systematic Assessment |
|
| Postural hypotension | Vascular disorders | Ds Navigator | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D052801 |
| Male Urogenital Diseases |