Trials / Completed
CompletedNCT00818584
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 48 Hours – 120 Days
- Healthy volunteers
- Not accepted
Summary
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Detailed description
Subjects will be stratified by weight to receive one of two doses of study drug
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Micafungin | IV Administration |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2009-01-07
- Last updated
- 2013-03-06
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00818584. Inclusion in this directory is not an endorsement.