An evaluative study to assess the safety of Nanocelle (Trademark) Atorvastatin Formulation Administered Oro-buccally (by mouth spray) in Healthy Adult Volunteers.
- Conditions
- HyperlipidaemiaCardiovascular - Other cardiovascular diseasesMetabolic and Endocrine - Other metabolic disorders
- Registration Number
- ACTRN12615001285549
- Lead Sponsor
- Medlab Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 12
1) Participants greater than or equal 18 years of age up to and including 80 years ago at time of entry on study 2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment 3) Participants agree to undergo venepuncture on multiple occasions 4) Participants agree to adhere to the study protocol 5) Hyperlipidaemic 6) Normal ECG reading QTcF < 450 msec 7) No history of statins reaction
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs 2) Previous history of rhabdomyolysis 3) Alcohol abuse 4) The use of any illicit drugs 5) Pregnancy or nursing an infant 6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant 7) Elevated liver enzymes 2x normal limits
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method