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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence TR | Experimental | 6 healthy subjects assigned to the sequence TR were administrated intravenously for 120 mins with the test product of amphotericin B liposome for injection in period 1 and the reference product of AmBisome® in period 2. |
|
| Sequence RT | Experimental | 6 healthy subjects assigned to the sequence RT were administrated intravenously for 120 mins with the reference product of AmBisome® in period 1 and the test product of amphotericin B liposome for injection in period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphotericin B liposome for injection | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Cmax | 90% CI of Cmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%~125.00%. | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| Bioequivalence based on AUC0-t | 90% CI of AUC0-t of liposome-encapsulated andnon-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%~125.00%. | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| Bioequivalence based on AUCinf | 90% CI of AUC0-∞ of liposome-encapsulated and non-liposome-encapsulated Amphotericin B between Amphotericin B liposome for injection and AmBisome® within 80.00%~125.00%. | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of liposome-encapsulated and non-liposome-encapsulated Amphotericin B | Time of maximum observed concentration | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| t1/2 of liposome-encapsulated and non-liposome-encapsulated Amphotericin B |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Medical Treatment Center | Wuhan | Hubei | 430040 | China |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| D007267 | Injections |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| AmBisome® | Drug | IV infusion |
|
|
Terminal elimination half-life |
| predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| λz of liposome-encapsulated and non-liposome-encapsulated Amphotericin B | Apparent elimination rate constant | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| Residual area of liposome-encapsulated and non-liposome-encapsulated Amphotericin B | Extrapolated area | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| Number of treatment-emergent adverse events for the test and the reference products | predose, 0.5, 1.0, 1.5, 2.0,2.25,2.5,3.0,4.0,6.0,8.0,10.0,14.0,26.0,50.0,74.0,146,218,290,362,434,506,578,674 hours after intravenous infusion |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |