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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 is a Phase 1 study that has completed, run by Javelin Pharmaceuticals. The registered enrollment target is 37 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00805090
The ClinicalTrials.gov registry entry for NCT00805090 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Javelin Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diclofenac Sodium is the first listed.
NCT00805090 reports 0 study locations.
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.
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