Trials / Completed
CompletedNCT01652859
An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
An Open-label, Randomized, Balanced, Crossover Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Taiwan Liposome Company · Industry
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Liposomal Amphotericin B | |
| DRUG | AmBisome |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2012-07-30
- Last updated
- 2013-11-27
Source: ClinicalTrials.gov record NCT01652859. Inclusion in this directory is not an endorsement.