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GLYCEROL PHENYLBUTYRATE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of multiple doses of RAVICTI 13.2 g/day and 19.8 g/day (approximately 69% and 104% of the maximum recommended daily dosage) on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment-arm, crossover study in 57 healthy subjects. The upper bound of the one-sided 95% CI for the largest placebo-adjusted, baseline-corrected QTc, based on individual correction method (QTcI) for RAVICTI, was below 10 ms.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- A16AX09 - glycerol phenylbutyrate
- A16AX - Various alimentary tract and metabolism products
- A16A - OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
- A16 - OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
- A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:GLYCEROL PHENYLBUTYRATE
Active Ingredient UNII:ZH6F1VCV7B
Drugbank ID:DB08909
PubChem Compound:10482134
CTD ID:C570223
CAS Number:611168-24-2
Dosage Form(s):liquid
Route(s) Of Administrator:oral
Daily Dose:
- 15000.0 mg/day A16AX09
Chemical Structure: 
SMILE Code:
O=C(CCCC1=CC=CC=C1)OCC(COC(=O)CCCC1=CC=CC=C1)OC(=O)CCCC1=CC=CC=C1
O=C(CCCC1=CC=CC=C1)OCC(COC(=O)CCCC1=CC=CC=C1)OC(=O)CCCC1=CC=CC=C1
Reference
N/A
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