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COMPLETED
NCT07644169
NA

A Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure

Sponsor: American Beverage Association

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine the translation of propylene glycol (PG) exposure in beverages to circulating PG levels to better understand the margin of safety in healthy participants. The main question it aims to answer is what is the maximum concentration (Cmax) of propylene glycol (PG) in serum following consumption of one, two, or three PG-containing beverages? Participants will be asked to: * Consume 1x, 2x, and 3x 12oz of PG-containing beverage * Have their blood drawn * Complete urine pregnancy testing if of childbearing potential * Complete a study diary and record their food and beverage consumption * Have their vital signs and oxygen measurements taken

Official title: An Open-label, Dose-escalation Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-07-09

Completion Date

2026-09-03

Last Updated

2026-09-29

Healthy Volunteers

Yes

Interventions

OTHER

Propylene glycol

At Visits 2, 4, and 6, participants will consume 1X, 2X, and 3X 12 oz of a PG-containing beverage (in bottle format) with standardized meals in the presence of the study staff over the course of the dosing day. Participants will consume the beverage and standardized meal within 15 minutes. The only beverage allowed during the visit - other than the intent-to-treat beverage - will be water.

Locations (1)

KGK Science Inc.

London, Ontario, Canada