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Pharmacokinetic, Safety and Tolerance Study of Three Doses Levels of Micafungin (FK463) in Premature Infants

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.

N/A

Astellas Study ID

The unique identification code given by the study sponsor.

99-0-063

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Yeast Fungal Infections

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

N/A - 40 Weeks

Sex

Female & Male

Product

micafungin

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jan 2001 - Jun 2002

Masking

None (Open Label)

Enrollment number

23

Pharmacokinetic, Safety and Tolerance Study of Three Doses Levels of Micafungin (FK463) in Premature Infants

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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