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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | Experimental | Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route |
|
| Meal 1: Plumpy Nuts | Experimental | Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route |
|
| Meal 2: Rice + beans | Experimental | Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexinidazole | Drug | Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of AEs | To assess safety and tolerability of fexinidazole tablets administered as single oral dose under fasting conditions and after two different meals in healthy male volunteers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lionel Hovsepian, MD | SGS Aster | Principal Investigator |
| Antoine Tarral, MD | Drugs for Neglected Diseases initiative | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Aster s.a.s. | Paris | 75015 | France |
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| Label | URL |
|---|---|
| Sponsor website | View source |
| Publication combining results of NCT00982904 \& NCT01483170 | View source |
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| ID | Term |
|---|---|
| C038307 | fexinidazole |
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