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The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects.
The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drug:FMTN fasted in P1,low-fat diet in P2,high-fat diet in P3 FMTN administration in fasted condition in period 1,FMTN administration after low-fat diet in period 2,FMTN administration after high-fat diet in period 3 |
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| 2 | Experimental | Drug:FMTN high-fat diet in P1,fasted in P2,low-fat diet in P3 FMTN administration after high-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after low-fat diet in period 3 |
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| 3 | Experimental | Drug:FMTN low-fat diet in P1,high-fat diet P2,fasted in P3 FMTN administration after low-fat diet in period 1,FMTN administration after high-fat diet in period 2,FMTN administration in fasted condition in period 3 |
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| 4 | Experimental | Drug:FMTN fasted in P1,high-fat diet P2,low-fat diet in P3 FMTN administration in fasted condition in period 1,FMTN administration after high-fat diet in period 2,FMTN administration after low-fat diet in period 3 |
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| 5 | Experimental | Drug:FMTN low-fat diet in P1,fasted P2,high-fat diet in P3 FMTN administration after low-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after high-fat diet in period 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMTN | Drug | Single dose of FMTN after high-fat meal,low-fat meal and fast |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration for FMTN | Day 1:0-192 hours (h) ;Day10:0-192 h; Day 19:0-19h |
| AUC0-t | Area under the concentration-time curve form 0(pre-dose) to time of last concentration of FMTN | Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-192 h |
| AUC0-inf | Area under the concentration-time curve form 0(pre-dose) to infinite time of FMTN | Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-19 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | China |
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| 6 | Experimental | Drug:FMTN high-fat diet in P1,low-fat diet P2,fasted in P3 FMTN administration after high-fat diet in period 1,FMTN administration after low-fat diet in period 2,FMTN administration in fasted condition in period 3 |
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