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Dutasteride-Test product · 1 trial · 1 indication
Blood samples will be collected for PK analyses in each period before dosing (0 hour) and at the following times after the dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours.
Blood samples will be collected for PK analyses in each period before dosing (0 hour) and at the following times after the dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours.
| Arm | Type | Description |
|---|---|---|
| Sequence 1-Dutasteride test product and then Reference product | EXPERIMENTAL | Participants will receive treatment A in period 1 and treatment B in period 2. Where treatment A= dutasteride 0.5 mg capsule test product, treatment B= dutasteride 0.5 mg capsule reference product. |
| Sequence 2-Dutasteride reference product and then test product | EXPERIMENTAL | Participants will receive treatment B in period 1 and treatment A in period 2. Where treatment A= dutasteride 0.5 mg capsule test product, treatment B= dutasteride 0.5 mg capsule reference product. |
| Name | Type | Description |
|---|---|---|
| Dutasteride-Test product | DRUG | Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by GSK, Poznan. |
| Dutasteride-Reference product | DRUG | Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Glycerin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by Catalent, Beinheim. |
Inclusion Criteria: * Between 20 and 64 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monito...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | - | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | N/A | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | N/A | Undisclosed |
| Profound Medical Corp | PROF | 1 | - | Undisclosed |
Dutasteride-Test product is a small molecule being developed for prostatic hyperplasia, a condition involving enlargement of the prostate gland. It is currently in Phase 1 clinical development as an investigational drug and has not been approved for marketing.
Dutasteride-Test product is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The drug is currently in Phase 1 clinical development for prostatic hyperplasia.
Dutasteride-Test product is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 1 clinical trial has been completed for this product.
Dutasteride-Test product has one completed clinical trial, identified as NCT02578953. This was a Phase 1 bioequivalence study of dutasteride capsules in healthy Japanese male subjects, with 36 participants enrolled. The trial was conducted in Japan.
Dutasteride-Test product is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for prostatic hyperplasia. The drug has not completed the clinical trials and regulatory review process required for marketing approval.