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NCT00805090 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Javelin Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT00805090: Completed Phase 1 study, sponsored by Javelin Pharmaceuticals.
NCT00805090 is a Phase 1 study that has completed, run by Javelin Pharmaceuticals. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00805090, a Phase 1 study, has completed, sponsored by Javelin Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
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 patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label, crossover study in which they will receive Sporanox® to compare the safety and pharmacokinetics of HPβCD when administered in DIC075V compared to Sporanox®.
Interventions
- DRUG Diclofenac Sodium
- DRUG Sporanox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00805090 record still lists
NCT00805090 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Diclofenac Sodium is the first listed.
NCT00805090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00805090 about?
NCT00805090 is a clinical study titled "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". 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 patients with mild chronic hepatic impairment compared. Additionally, the healthy adult volunteers will participate in a randomized, open-label...
What is the current status of trial NCT00805090?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2008-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00805090?
The interventions under investigation include: Diclofenac Sodium (DRUG), Sporanox (DRUG).
Who is sponsoring clinical trial NCT00805090?
This trial is sponsored by Javelin Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00805090's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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