CLINICAL TRIALS PROFILE FOR FEXINIDAZOLE
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All Clinical Trials for FEXINIDAZOLE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00982904 ↗ | Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole | Completed | Sanofi | Phase 1 | 2009-09-01 | This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy. |
| NCT00982904 ↗ | Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole | Completed | Drugs for Neglected Diseases | Phase 1 | 2009-09-01 | This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy. |
| NCT01340157 ↗ | Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions | Completed | Sanofi | Phase 1 | 2011-02-01 | The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration. |
| NCT01340157 ↗ | Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions | Completed | Drugs for Neglected Diseases | Phase 1 | 2011-02-01 | The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration. |
| NCT01483170 ↗ | Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food | Terminated | Drugs for Neglected Diseases | Phase 1 | 2011-09-01 | This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days. |
| NCT01685827 ↗ | Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 | Completed | Drugs for Neglected Diseases | Phase 2/Phase 3 | 2012-10-01 | This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not inferior to NECT treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for FEXINIDAZOLE
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Clinical Trial Sponsors for FEXINIDAZOLE
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