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Tamsulosin

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Tamsulosin · 2 trials · 1 indication

Phase 1 2
NCT01149746Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting ConditionsHealthy
COMPLETED32 Analytics
NCT01149733Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed ConditionsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions
Healthy
NCT0114974632
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PHASE1COMPLETED
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
Healthy
NCT0114973332
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Study Endpoints

Primary Endpoints

Cmax (maximum observed concentration of drug substance in plasma)
Blood samples drawn over 60 hour time period

Bioequivalence based on Cmax

AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Blood samples drawn over 60 hour time period

Bioequivalence based on AUC0-t

AUC0-inf (area under the concentration-time curve from time zero to infinity)
Blood samples drawn over 60 hour time period

Bioequivalence based on AUC0-inf

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
TamsulosinEXPERIMENTAL0.4 mg Capsule
Flomax®ACTIVE_COMPARATOR0.4 mg Capsule

Interventions

NameTypeDescription
TamsulosinDRUGTest 0.4 mg Capsule
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, non-smoking male subjects, 18 years of age or older. * BMI greater than or equal to 19 and less than or equal to 30. * Negative for: * HIV. * Hepatitis B surface antigen and Hepatitis C antibody. * Using drugs of abuse test (marijuana, amphetamines, barbiturate...

Countries:Canada
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Frequently asked questions about Tamsulosin

What is Tamsulosin used for?

Tamsulosin is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). In the clinical trials listed, it is being studied in healthy male volunteers. The trials are bioavailability studies of Tamsulosin Hydrochloride 0.4 mg capsules under fed and fasting conditions, with a total enrollment of 64 participants.

Who makes Tamsulosin?

Tamsulosin is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of Tamsulosin Hydrochloride 0.4 mg capsules in healthy volunteers.

What phase is Tamsulosin in?

Tamsulosin is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy male volunteers. The drug is investigational and has not been approved for any indication based on the available data.

What clinical trials is Tamsulosin in?

Tamsulosin has two completed Phase 1 trials: NCT01149733, a study of Tamsulosin Hydrochloride 0.4 mg capsules under fed conditions, and NCT01149746, a study under fasting conditions. Both trials enrolled 32 healthy male participants each in Canada, with a minimum age of 18 years.

Is Tamsulosin the same as Tamsulosin Hydrochloride?

Tamsulosin is the active ingredient in Tamsulosin Hydrochloride, which is the salt form used in the 0.4 mg capsules studied in the clinical trials. The trials refer to the drug as Tamsulosin Hydrochloride 0.4 mg capsules, indicating that Tamsulosin Hydrochloride is the formulation being tested.