Clinical trial
An Open-Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of DIC075V in Subjects With Mild or Moderate Chronic Renal Insufficiency and in Subjects With Mild Chronic Hepatic Impairment Compared to Healthy Adult Volunteers and a Randomized, Open-Label, Single-Dose, Two-Way, Crossover Study to Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Adult Volunteers.
NCT00805090 is registered in ClinicalTrials.gov with Javelin Pharmaceuticals as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- An Open-Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of DIC075V in Subjects With Mild or Moderate Chronic Renal Insufficiency and in Subjects With Mild Chronic Hepatic Impairment Compared to Healthy Adult Volunteers and a Randomized, Open-Label, Single-Dose, Two-Way, Crossover Study to Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Adult Volunteers.
- Lead sponsor
- Javelin Pharmaceuticals
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- December 31, 2008
- Completion date
- April 30, 2009
- Enrollment
- 37 (actual)
- Sites
- 4
Conditions
As the registry lists them; a condition with its own page is linked.