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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...
It is a fixed-dose oral capsule that combines dutasteride 0.5 mg with tamsulosin hydrochloride 0.4 mg. GSK plc, which trades as GSK, developed this combination product, and it is studied in urologic diseases within the nephrology therapeutic area. Both components are small molecules.
GSK plc, ticker GSK, is the developer of this dutasteride and tamsulosin hydrochloride combination capsule. The company ran the bioequivalence program for the second generation formulation of the product, with studies conducted in the United Kingdom.
The program is at Phase 1. Two Phase 1 bioequivalence trials of the second generation dutasteride and tamsulosin HCl combination capsule have been completed, and no trials are currently active. Total enrollment across the two completed studies was 155 participants.
Two completed Phase 1 bioequivalence trials are registered. NCT02058576 evaluated the second generation combination capsule in the fed state with 77 participants, and NCT02052713 evaluated it in the fasted state with 78 participants. Both were controlled, randomized studies in the United Kingdom.
Both trials enrolled healthy male volunteers aged 18 years and older. NCT02058576 enrolled 77 participants and NCT02052713 enrolled 78, for a combined total of 155. The studies were randomized and controlled, and neither was double blind.