NanoStat™ (NanoCelle® Atorvastatin) for the Lowering of Cholesterol
Study Site:
Zenith Technology CorporationFormulation:
A single dose, blinded, balanced, randomised, two-treatment, two period, two sequence, two-way crossover pilot study comparing the pharmacokinetics of 1 x 8 mg atorvastatin oral spray (Medlab Clinical, Australia) with 1 x 20 mg Lipitor® capsule (Pfizer, Australia) in healthy subjects under fasting conditions.
About Trial:
The program investigates a nanoparticle API used as an adjuvant to enhance the efficacy of Atorvastatin.
Atorvastatin belongs to a group known as "statins" for preventing heart disease, strokes and attacks. Atorvastatin is commonly prescribed for the lowering of a patient's cholesterol.
Side effects are well documented, most serious of note are rhabdomyolysis and autoimmune myopathy. Evidence to date indicates that statins can cause either self-limited myotoxicity, presumably due to the direct effect of statins in the muscle, or an autoimmune myopathy associated with autoantibodies targeting HMGCR.
Source: Pinal-Fernandez I, Casal-Dominguez M, Mammen AL. Statins: pros and cons. Med Clin (Barc). 2018;150(10):398-402. doi:10.1016/j.medcli.2017.11.030.
Atorvastatin has a significant bioavailability problem cited at 12%.
This program looks at establishing a NanoCelle® Atorvastatin (named NanoStat™) with improved bioavailability without increasing the drug risk profile.
HREC Date:
2017-07-04HREC Date:
2017-07-04HREC ID:
17/STH/106CTN:
CT-2015-CTN–0180-0-v1PARTNER'S ASSOCIATED WITH THE PROGRAM
ZenTech
Zenith Technology (ZenTech) was incorporated in 1987 and is an independent ISO 9001:2008 certified contract research organisation (CRO) providing clinical trial and analytical laboratory services to GCP and GLP standards, for the international pharmaceutical industry.
ZenTech has an analytical laboratory and a dedicated clinical site capable of housing up to 60 participants at one time, providing the complete package from protocol development to report submission. Our reports have been successfully evaluated and accepted by NZ Medsafe, the Australian Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA), and European Union Medicines Agency (EMA). Our facilities and processes have been successfully inspected and approved by the FDA and EMA.
For more information about ZenTech visit http://www.zenithtechnology.co.nz/about-us/index.cfm
