Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
kg azithromycin, kg azithromycin IR · 1 trial · 1 indication
AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.
| Arm | Type | Description |
|---|---|---|
| 1. | ACTIVE_COMPARATOR | 60 mg/kg azithromycin ER (Extended Release)arm |
| 2. | ACTIVE_COMPARATOR | 30 mg/kg azithromycin IR (Immediate Release) arm |
| Name | Type | Description |
|---|---|---|
| 60 mg/kg azithromycin ER | DRUG | subjects taken 60 mg/kg azithromycin ER |
| 30 mg/kg azithromycin IR | DRUG | subjects taken 30 mg/kg azithromycin IR (Immediate Release) |
Inclusion Criteria: * Subjects age 6 months to \< 12 years. * Have clinical signs/symptoms of acute otitis media in at least one ear. * Parent(s)/legal guardian(s) provide written informed consent. Exclusion Criteria: * Clinical significant other disease. * Recent use of investigational drugs, pr...
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.