Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease

Apsen Farmaceutica S.A.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Meniere Disease Vertigo Vertigo Vestibular

Interventions

APSLXRDRUG

Oral coated tablets once a day for 60 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Incidence of Adverse Events

Time frame: during 60 days

Secondary Outcomes

Pharmacokinetic parameters in steady state

Cmáx\_SS

Time frame: at Day 60

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.