Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as commercially available dutasteride
Commercially available combination of dutasteride and tamsulosin · 2 trials · 1 indication
PK parameters include: area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC \[0-t\]), and maximum observed concentration (Cmax) as data permit
PK parameters include: AUC\[0-t\]), area under the concentration-time curve from time zero extrapolated to infinite time (AUC\[0-infinity\]) \[defaulting to AUC(0-t)
PK parameters include: area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC \[0-t\]), and maximum observed concentration (Cmax) as data permit.
PK parameters include: AUC\[0-t\]), area under the concentration-time curve from time zero extrapolated to infinite time (AUC\[0-infinity\]) \[defaulting to AUC(0-t)
| Arm | Type | Description |
|---|---|---|
| Sequence AB | EXPERIMENTAL | Subjects will receive Treatment A (commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg) in period 1 and Treatment B (combination of second generation dutasteride 0.5 mg and tamsulosin HCl 0.4 mg combination) in period 2 orally once daily under fasted condition. |
| Sequence BA | EXPERIMENTAL | Subjects will be randomized to receive Treatment B (combination of second generation dutasteride 0.5 mg and tamsulosin HCl 0.4 mg combination) in period 1 and Treatment A (commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg) in period 2 orally once daily under fasted condition.\[dutasteride 0.5 mg and tamsulosin HCl 0.4 mg) in period 2 orally once daily under fasted condition. |
| Name | Type | Description |
|---|---|---|
| Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg | DRUG | Commercially available, orange and brown, hard shell capsule, administered orally as a single dose on Day 1 under fasted condition. |
| Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule | DRUG | Orange and brown, hard shell capsule, administered orally, as a single-dose on Day 1 under fasted condition. |
Inclusion Criteria: * Males who are 18 to 50 years of age, inclusive. * Weight range 55 to 95 kg (inclusive) and body mass index (BMI) 18 to 30 kilogram/meter\^2 (kg/m\^2) (inclusive). * Healthy subjects defined as individuals who are free from clinically significant illness or disease as determine...