| Trial ID: | L1400 |
| Source ID: | NCT00805090
|
| Associated Drug: |
Sporanox
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic|Hepatic Insufficiency|Healthy
|
| Interventions: |
DRUG: Sporanox|DRUG: Diclofenac Sodium
|
| Outcome Measures: |
Primary: To evaluate the safety and pharmacokinetics of diclofenac and HPβCD following a single-dose of DIC075V in subjects with mild or moderate chronic renal insufficiency and in subjects with mild hepatic impairment compared to healthy adult volunteers., Screening - Follow-up | Secondary: To evaluate the safety and pharmacokinetics of HPβCD following a single-dose of DIC075V and Sporanox in healthy adult volunteers., Screening - Follow-up
|
| Sponsor/Collaborators: |
Sponsor: Javelin Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
37
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: |Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2008-12
|
| Completion Date: |
2009-04
|
| Results First Posted: |
|
| Last Update Posted: |
2009-04-30
|
| Locations: |
Orlando Clinical Research Center, Orlando, Florida, 32809, United States|Davita Clinical Research, Minneapolis, Minnesota, 55404, United States|New Orleans Clinical Center for Research, Knoxville, Tennessee, 37920, United States|Simbec Research, Ltd., Merthyr Tydfil, CF48 4DR, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00805090
|
