Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test formulation, Reference formulation · 1 trial · 1 indication
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
| Arm | Type | Description |
|---|---|---|
| Part 1: Treatment A | EXPERIMENTAL | Single 200mg IM testosterone cypionate solution (Test formulation) |
| Part 1: Treatment B | ACTIVE_COMPARATOR | Single 200 mg IM testosterone cypionate solution (Reference formulation) |
| Part 2: Treatment A | EXPERIMENTAL | Single 200 mg IM testosterone cypionate solution (Test formulation) |
| Part 2: Treatment B | ACTIVE_COMPARATOR | Single 200 mg IM testosterone cypionate solution (Reference formulation) |
| Name | Type | Description |
|---|---|---|
| Test formulation | BIOLOGICAL | A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation). |
| Reference formulation | BIOLOGICAL | A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation). |
Inclusion Criteria: 1. Hypogonadal male subjects who, at the time of screening, are otherwise healthy and between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood p...
1 mg, 5 mg, 10 mg is an investigational drug being studied for use in meningococcal vaccine, non-Hodgkin lymphoma, growth disorder, acute otitis media, hypogonadism, and healthy volunteers. It is currently in Phase 1 clinical development.
1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 1 clinical development.
1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791, NCT00039910, NCT00174421, and NCT01163851. These trials have investigated its use in conditions such as thrombocytopenia, non-Hodgkin lymphoma, growth disorder, and hypercholesterolemia.
1 mg, 5 mg, 10 mg is also known as PN-152,243 and PN-196,444 in clinical trials. These names refer to the same investigational drug being developed by Pfizer.