drugset / Trial / NCT02286609
A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics
Non-randomizedSingle-groupOpen-labelBasic science
Summary
This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age, body mass index \[BMI\], and gender).
Timeline
- Start
- 2014-12
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deflazacort | Other / unclassified | 18 mg | Oral |
Indications
No indication recorded.