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A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)

2014-08-27 03:19:19 | BioPortfolio

Summary

To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.

Description

A randomized, open-label, four-treatment, four-period crossover study in which healthy male subjects received a single dose of each of the following four treatments on four separate dosing days, 7 days apart:

- Oral sodium phenylbutyrate (Buphenyl®) equivalent to 3 g/m2 of 4-phenylbutyric acid (PBA) per dose

- Oral GT4P-F mole equivalents to 3 g/m2 of PBA per dose

- Oral GT4P-API mole equivalents to 3 g/m2 of PBA per dose

- Intravenous 10% sodium phenylacetate plus 10% sodium benzoate (Ammonul®) 2.75 g/m2

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

HPN-100, Ammonul, Buphenyl

Location

Medical Sanitary Division #2
Kharkiv
Ukraine
61011

Status

Completed

Source

Hyperion Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:19-0400

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