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Dutasteride; Tamsulosin; fixed dose combination product of duatsteride and tamsulosin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Fixed dose combination product | EXPERIMENTAL | Fixed Dose Combination capsule containing dutasteride 0.5mg and tamsulosin 0.2 mg |
| Name | Type | Description |
|---|---|---|
| Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg) | DRUG | In the first dosing session, twenty-two subjects of each cohort will receive the FDC capsule (dutasteride and tamsulosin hydrochloride (0.5mg/0.2mg) and the other 22 will receive commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg co-administered. Following a wash-out period of at least 28 days, those subjects who received the FDC capsule in session 1, will be co-administered commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg while those who were co-administered commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg in session 1 will receive the FDC capsule in the second dosing session. |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...
Top 1 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Medicus Pharma Ltd | MDCX | 1 | PHASE2 | Teverelix DP |
The dutasteride and tamsulosin fixed dose combination is being studied for prostatic hyperplasia, also known as benign prostatic hyperplasia or BPH. It combines dutasteride 0.5mg and tamsulosin hydrochloride 0.2mg in a single product. The recorded clinical development for this combination is at Phase 1.
GSK plc, which trades under the ticker GSK, is the developer of the fixed dose combination product of dutasteride 0.5mg and tamsulosin hydrochloride 0.2mg. The company sponsored the bioavailability study of this combination in healthy male volunteers.
The dutasteride and tamsulosin fixed dose combination is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are recorded. It is an investigational product and is not described as approved.
One completed Phase 1 trial, NCT01254071, evaluated the bioavailability of the fixed dose combination of dutasteride 0.5mg and tamsulosin hydrochloride 0.2mg relative to co-administration of the individual components. It enrolled 86 healthy male subjects of North East Asian and non-Asian ancestry in Australia.
No. The fixed dose combination product contains both dutasteride 0.5mg and tamsulosin hydrochloride 0.2mg in one product, while dutasteride and tamsulosin are also used as separate individual components. The completed Phase 1 trial compared the combination against co-administration of those individual components.
Dutasteride and tamsulosin are small molecule agents. Dutasteride and tamsulosin act through distinct pharmacological targets, and the fixed dose combination brings both agents together in a single product for prostatic hyperplasia. The completed Phase 1 trial assessed the bioavailability of the combination.