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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02578953 | Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects | PHASE1 | COMPLETED | 36 | — | — | Sep 9, 2015 | Dec 15, 2015 | Jun 19, 2018 | 1 | Japan |
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 | NA | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | NA | Undisclosed |
| Profound Medical Corp | PROF | 1 | — | Undisclosed |