Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sodium Glycerophosphate Injection
Glycerophosphate · 1 trial · 1 indication
Serum PK parameter
Serum PK parameter
| Arm | Type | Description |
|---|---|---|
| Sequence AB (Organic phosphate/ Inorganic phosphate) | EXPERIMENTAL | * Period 1: Regimen A (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP)) |
| Sequence BA (Inorganic phosphate/ Organic phosphate) | EXPERIMENTAL | * Period 1: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP)) * Period 2: Regimen A (Organic phosphate (sodium glycerophosphate SGP)) |
| Name | Type | Description |
|---|---|---|
| Sodium Glycerophosphate Injection | DRUG | Organic phosphate (SGP) will be diluted with 500mL of sodium chloride (0.9% normal saline) to achieve an equimolar IV phosphate dose of 60 mmol over 4 hours (h) |
| Sodium Phosphates Injection | DRUG | Inorganic phosphate (NaP) will be diluted with 500mL of sodium chloride (0.9% normal saline) to achieve an equimolar IV phosphate dose of 60 mmol over 4 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 ...
Glycerophosphate is an organic phosphate small molecule being developed for parenteral nutrition, where it is intended to supply phosphate to patients who cannot take nutrition by mouth. It is also known as Sodium Glycerophosphate Injection. Baxter International Inc. is developing it, and it has been studied in a single completed Phase 1 trial.
Glycerophosphate is being developed by Baxter International Inc., which trades on the New York Stock Exchange under the ticker BAX. The company sponsored the Phase 1 bioequivalence study of Sodium Glycerophosphate Injection conducted in the United States.
Glycerophosphate is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a randomized, double-blind, controlled bioequivalence trial that enrolled 42 healthy adult volunteers in the United States.
Glycerophosphate has been evaluated in one completed Phase 1 trial, NCT06842121, titled A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP). The trial enrolled 42 healthy volunteers aged 18 years and older in the United States and compared the two phosphate formulations.
Yes. Sodium Glycerophosphate Injection is another name for Glycerophosphate, the organic phosphate small molecule developed by Baxter International Inc. for parenteral nutrition. The Phase 1 bioequivalence trial NCT06842121 used the Sodium Glycerophosphate Injection name in its title.