NCT06842134

A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E

Phase 1, Prospective, Single-Center, Randomized Sequence, Open Label, 2-Way Crossover Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, prospective, single-center, randomized sequence, open label, 2-way crossover study comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E. It is planned to randomize approximately 16 healthy male and female subjects. All study periods will be completed during a single residency, the overall duration of residency will be 11 days (10 nights).

Conditions

• Parenteral Nutrition

Interventions

Type	Name	Description
DRUG	Numeta G16%E	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.
DRUG	Sodium Glycerophosphate Injection	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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2025-02-24
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study