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DESF · OASIS
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome
Ensayo de Aquestive Therapeutics, Inc. en Reaccion alergica.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 36
- Centros
- 1
- Fin del objetivo primario
- oct 2024
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2024.
Qué mide
Cmax (0 to 240 minutes post-dose) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroA 2-part open-label study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as single and repeat doses of DESF in healthy adults with oral allergy syndrome (OAS). In both parts, subjects undergo an oromucosal allergen challenge prior to administration of DESF according to randomization into two cohorts. In Part 1, there are three treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1), intramuscular (IM) injection without allergen challenge (Treatment Period 2), and DESF without allergen challenge (Treatment Period 3). In Part 2, there are two treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1) and intramuscular (IM) injection without allergen challenge (Treatment Period 2).
Más ensayos de AQST
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| DESF · PARKS | Fase 1 | Completado | mar 2025 (real) |
| Diazepam Buccal Soluble Film 5 · DBF | Fase 3 | Completado | jun 2020 (real) |
| Diazepam Buccal Film | Fase 2 | Completado | ene 2020 (real) |
| Diazepam Buccal Film | Fase 1/2 | Completado | jul 2019 (real) |
| Riluzole Oral Soluble film · ROSF | Fase 2 | Interrumpido | sep 2018 (real) |
| Diazepam Buccal Film 12.5 mg | Fase 2 | Completado | jul 2018 (real) |
Todos los de AQST, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06527937), actualizada en sep 2025.