Trials / Completed
CompletedNCT04993222
A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
A Randomized, Open-label, Two-preparation, Single-dose, Two-sequence Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amphotericin B liposome for injection | IV infusion |
| DRUG | AmBisome® | IV infusion |
Timeline
- Start date
- 2020-06-04
- Primary completion
- 2020-09-08
- Completion
- 2020-11-16
- First posted
- 2021-08-06
- Last updated
- 2021-08-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04993222. Inclusion in this directory is not an endorsement.