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An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects

NCT01652859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-11-27

No results posted yet for this study

Summary

The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different liposomal amphotericin B injections after single IV infusion at the same dose in normal healthy subjects.

Conditions

  • Normal Healthy Subjects

Interventions

DRUG

Liposomal Amphotericin B

DRUG

AmBisome

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-12-31
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01652859 on ClinicalTrials.gov