Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06842121 | A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP) | PHASE1 | COMPLETED | 42 | — | — | Jan 27, 2025 | May 22, 2025 | Jun 29, 2025 | 1 | United States |
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 ...