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A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)

NCT06842121 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-06-29

No results posted yet for this study

Summary

This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate Injection (NaP).

In this study it is planned to randomize approximately 42 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

Sodium Glycerophosphate Injection

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)

DRUG

Sodium Phosphates Injection

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

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
DOUBLE
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 NCT06842121 on ClinicalTrials.gov