Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01149746 | Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 32 | — | — | Dec 1, 2004 | Dec 1, 2004 | Jun 23, 2010 | 1 | Canada |
| NCT01149733 | Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions | PHASE1 | COMPLETED | 32 | — | — | Nov 1, 2004 | Nov 1, 2004 | Aug 20, 2024 | 1 | Canada |
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...