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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01330303

First received: August 30, 2010

Last updated: May 19, 2011

Last verified: May 2011

History of Changes

Results First Received: March 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Conditions:	Healthy Volunteers Prostatic Hyperplasia
Interventions:	Drug: Reference formulation Drug: Test formulation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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
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

Participant Flow for 3 periods

Period 1: Period 1

	Test Product in Period 1; Reference Product in Period 2	Reference Product in Period 1; Test Product in Period 2
STARTED	20	20
COMPLETED	19	18
NOT COMPLETED	1	2
Adverse Event	1	0
Protocol Violation	0	1
Withdrawal by Subject	0	1

Period 2: 7-Day Washout Period

	Test Product in Period 1; Reference Product in Period 2	Reference Product in Period 1; Test Product in Period 2
STARTED	19	18
COMPLETED	19	18
NOT COMPLETED	0	0

Period 3: Period 2

	Test Product in Period 1; Reference Product in Period 2	Reference Product in Period 1; Test Product in Period 2
STARTED	19	18
COMPLETED	19	18
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Participants Receiving Both Test Product and Reference Product
Number of Participants [units: participants]	40
Age [units: Years] Mean ± Standard Deviation	30.20 ± 7.36
Gender [units: Participants]
Female	0
Male	40
Race/Ethnicity, Customized [units: participants]
Caucasian	35
Mulatto	3
Black	2

Outcome Measures

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1. Primary:

AUC 0-t [ Time Frame: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2) ]

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2. Primary:

AUC0-infinity [ Time Frame: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2) ]

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3. Primary:

Cmax [ Time Frame: Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2) ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
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
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

Other Adverse Events

	Test Product in Period 1; Reference Product in Period 2	Reference Product in Period 1; Test Product in Period 2
Total, other (not including serious) adverse events
# participants affected / at risk	6/20	8/20
Gastrointestinal disorders
Nausea ^{† 1}
# participants affected / at risk	1/20 (5.00%)	0/20 (0.00%)
Vomiting ^{† 1}
# participants affected / at risk	1/20 (5.00%)	0/20 (0.00%)
Investigations
Serum glutamic-pyruvic increased ^{† 1}
# participants affected / at risk	0/20 (0.00%)	1/20 (5.00%)
Gamma glutamyl transferase increased ^{† 1}
# participants affected / at risk	0/20 (0.00%)	1/20 (5.00%)
Glucose high ^{† 1}
# participants affected / at risk	0/20 (0.00%)	1/20 (5.00%)
Serum triglycerides increased ^{† 1}
# participants affected / at risk	0/20 (0.00%)	2/20 (10.00%)
Serum urea increased ^{† 1}
# participants affected / at risk	0/20 (0.00%)	3/20 (15.00%)
Serum bilirubin increased (total and indirect) ^{† 1}
# participants affected / at risk	0/20 (0.00%)	1/20 (5.00%)
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	1/20 (5.00%)	0/20 (0.00%)
Headache ^{† 1}
# participants affected / at risk	3/20 (15.00%)	0/20 (0.00%)
Respiratory, thoracic and mediastinal disorders
Sore throat ^{† 1}
# participants affected / at risk	1/20 (5.00%)	0/20 (0.00%)
Vascular disorders
Postural hypotension ^{† 1}
# participants affected / at risk	0/20 (0.00%)	1/20 (5.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, Ds Navigator

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01330303 History of Changes
Other Study ID Numbers:	114073
Study First Received:	August 30, 2010
Results First Received:	March 10, 2011
Last Updated:	May 19, 2011
Health Authority:	Brazil: Institutional Review Board Brazil: ANVISA

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