Overview
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-10-01
2022-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere's disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Apsen Farmaceutica S.A.
Criteria
Inclusion Criteria:- Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;
- Voluntarily consent to participate in the study;
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding;
- Participants presenting uncontroled systolic hipertension (>140/90 mmHg);
- Participants presenting uncontroled diabetes (blood glucose >200 mg/dL).