A Randomised, Placebo-Controlled, Double-Blind, Single Dose Escalation Study to evaluate the Safety, Tolerability and Pharmacokinetics of Betahistine Dihydrochloride Following a Single Intranasal Dose in Healthy Male and Female Volunteers.
Phase 1
Completed
- Conditions
- OME (Otitis Media with Effusion)Ear - Other ear disorders
- Registration Number
- ACTRN12613000892718
- Lead Sponsor
- Otifex Therapeutics Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy male and female volunteers having Body Mass Index (MBI) between 18 and 30kg/m2 inclusive.
Normal (Type A) tympanometric measurements at screening consistent with the normal healthy adult population.
Exclusion Criteria
History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular, or infectious disease; any acute infectious disease or signs of acute illness, especially of the ear, nose or throat (ENT).
History of recurrent ENT infections, irritation or localized reaction to intranasally applied agents.
Recent ENT surgery (within 3 months of screening).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method