Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Horizon Pharma Ireland, Ltd., Dublin Ireland
• To determine the safety and tolerability of multiple ascending, supratherapeutic doses of
• To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid
[PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead
electrocardiogram (ECG) parameters in healthy male and female subjects with the primary
endpoint being the time-matched change from baseline in the QT interval corrected for heart
rate (HR) based on an individual correction method (QTcI).
A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China
Yiling Pharmaceutical Inc.
1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol
Injection on multiple dose and single dose
2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with
Felbinac Trometamol Injection on multiple dose and single dose
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders
Not yet recruiting
Horizon Therapeutics, LLC
This is a randomized, controlled, open-label parallel arm study to assess the safety,
tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to NaPBA in urea
cycle disorder subjects not currently or previously chronically treated with phenylacetic
acid (phenylacetate; PAA) prodrugs. The study design will include: 1) Baseline Period; 2)
Initial Treatment Period; 3) a RAVICTI only Transition Period 4) a RAVICTI only Maintenance
Period; and 5) a RAVICTI only Safety Extension Period. The study will run for approximately
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