Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

April 30, 2009

Conditions
Renal Insufficiency, ChronicHepatic InsufficiencyHealthy
Interventions
DRUG

Sporanox

200 mg

DRUG

Diclofenac Sodium

37.5 mg

Trial Locations (4)

32809

Orlando Clinical Research Center, Orlando

37920

New Orleans Clinical Center for Research, Knoxville

55404

Davita Clinical Research, Minneapolis

CF48 4DR

Simbec Research, Ltd., Merthyr Tydfil

Sponsors
All Listed Sponsors
lead

Javelin Pharmaceuticals

INDUSTRY