Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tamiflu · 2 trials · 2 indications
CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose. CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed\[0-48\])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC\[0-48\]) CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed\[0-8\]/AUC\[0-8\] + Aed\[24-32\]/AUC\[24-32\]) / 2 CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed\[8-16\]/AUC\[8-16\] + Aed\[16-24\]/AUC\[16-24\] + Aed\[32-48\]/AUC\[32-48\]) / 3
AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration. The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.
CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).
Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule
Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis.
Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis
| Arm | Type | Description |
|---|---|---|
| Volunteers on dialysis | EXPERIMENTAL | - |
| Volunteers with reduced creatinine clearance | EXPERIMENTAL | - |
| Oseltamivir 3 mg | EXPERIMENTAL | infants 3 to \<12 months |
| Oseltamivir 2.5 mg | EXPERIMENTAL | infants 1 to \<3 months of age |
| Oseltamivir 2 mg | EXPERIMENTAL | infants 0 to 30 days (post natal) of age |
| Name | Type | Description |
|---|---|---|
| Tamiflu (oseltamivir) | DRUG | Single dose of Tamiflu in volunteers on dialysis |
| Tamiflu | DRUG | oral repeating dose |
Inclusion Criteria: General * Adult volunteers, aged 19 to 90 years * Medically stable with no hospitalization for a significant disease in the 3 months before study start Volunteers on dialysis * A documented and well-established dialysis therapy Volunteers with reduced creatinine clearance *...
Tamiflu is used for the treatment of influenza, including confirmed flu infection in infants 0 to <12 months of age, and for studies in healthy volunteers. It is an investigational small molecule being developed by Roche Holding AG for these indications.
Tamiflu is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug for influenza and in healthy volunteer studies.
Tamiflu is in Phase 1 clinical development. It is investigational and not yet approved, with clinical trials ongoing or completed to evaluate its safety and pharmacokinetics in influenza patients and healthy volunteers.
Tamiflu has been studied in two Phase 1 trials: NCT00988325, a PK/PD and safety evaluation in infants with confirmed flu infection, and NCT01556633, a single dose study in dialysis volunteers and those with reduced creatinine clearance. Both trials are completed.
Yes, Tamiflu is also known as oseltamivir. Clinical trials reference oseltamivir [Tamiflu] in their titles, confirming that the drug is the same compound.