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

NCT06842134 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-06-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Erika Ryan, DCN, MS, RD, CDN, CNSC · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2025-05-22
Completion
2025-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842134 on ClinicalTrials.gov