Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Flomax®
Tamsulosin · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
| Arm | Type | Description |
|---|---|---|
| Tamsulosin | EXPERIMENTAL | 0.4 mg Capsule |
| Flomax® | ACTIVE_COMPARATOR | 0.4 mg Capsule |
| Name | Type | Description |
|---|---|---|
| Tamsulosin | DRUG | Test 0.4 mg Capsule |
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...
Tamsulosin is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It is an antagonist that targets the alpha-1 adrenergic receptors ADRA1A, ADRA1D, and ADRA1B. The specific medical conditions it is being studied for have not been disclosed, and it is currently in Phase 1 clinical development.
Tamsulosin targets the alpha-1 adrenergic receptors ADRA1A, ADRA1D, and ADRA1B. It acts as an antagonist at these receptors, meaning it blocks their activity. This mechanism is being investigated in clinical trials, though the therapeutic area is classified as other and the indications are undisclosed.
Tamsulosin is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. The company is responsible for the clinical development of this small molecule drug, which is currently in Phase 1 testing.
Tamsulosin is in Phase 1 clinical development. It has completed two Phase 1 trials with a total enrollment of 64 participants. The drug is investigational and has not been approved by the FDA for any indication.
Tamsulosin has been studied in two completed Phase 1 trials: NCT01149746, which evaluated tamsulosin hydrochloride 0.4 mg capsules under fasting conditions, and NCT01149733, which tested the same capsules under fed conditions. Both trials enrolled 32 healthy male volunteers in Canada.