Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Numeta GE · 1 trial · 1 indication
Serum PK parameter
Serum PK parameter
| Arm | Type | Description |
|---|---|---|
| Sequence CD (Numeta G16%E/Organic phosphate) | EXPERIMENTAL | * Period 1: Regimen C (Numeta G16%E) * Period 2: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) |
| Sequence DC (Organic phosphate/Numeta G16%E) | EXPERIMENTAL | * Period 1: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen C (Numeta G16%E) |
| Name | Type | Description |
|---|---|---|
| Numeta G16%E | DRUG | Numeta G16%E (1000mL) will be given intravenously via peripherally inserted central catheter and will provide an equimolar IV phosphate dose of 8.7 mmol over 9 h. |
| Sodium Glycerophosphate Injection | DRUG | Organic phosphate (SGP) will be diluted 1000mL of sodium chloride (0.9% normal saline) to achieve an equimolar IV phosphate dose of 8.7 mmol over 9 h. |
Inclusion Criteria: 1. Healthy males or non-pregnant, non-lactating healthy females. 2. Aged 18 to 55 years, inclusive, at the time of signing informed consent. 3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 and a minimum body weight of 57 kg as measured at screening. 4. Must be willing and able ...
Numeta GE is used for parenteral nutrition, which is the delivery of nutrients directly into the bloodstream for patients who cannot eat or digest food normally. It is being studied as a source of nutrition in a clinical trial setting.
Numeta GE is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical research on this product for parenteral nutrition.
Numeta GE is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the product remains in early-stage clinical research.
Numeta GE was studied in a Phase 1 clinical trial with the identifier NCT06842134. This completed trial compared organic phosphate (sodium glycerophosphate injection) to Numeta G16%E in 16 healthy adult volunteers in the United States.
Numeta GE and Numeta G16%E are related products studied in the same clinical trial. The trial compared organic phosphate to Numeta G16%E, and Numeta GE is the product name used in the context of this research. They are not confirmed to be identical.