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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Amphotericin B | Experimental | Generic drug |
|
| AmBisome | Active Comparator | RLD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Amphotericin B | Drug |
| ||
| AmBisome |
| Measure | Description | Time Frame |
|---|---|---|
| The bioequivalence of two different liposomal amphotericin B injections | 90% CI of Cmax and AUCinf of Liposomal and non-liposomal Amphotericin B between Ambil and AmBisome within 80.00%~125.00%. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26768369 | Derived | Adler-Moore JP, Gangneux JP, Pappas PG. Comparison between liposomal formulations of amphotericin B. Med Mycol. 2016 Mar;54(3):223-31. doi: 10.1093/mmy/myv111. Epub 2016 Jan 14. |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
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