NanoStat (NanoCelle Atorvastatin)

CLINICAL TRIAL

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.

FORMULATION

NanoStatTM is an investigative new sub-micron spray delivering 8 mg Atorvastatin in four actuations of the pump applied to the oro-buccal membrane.

DATE of HREC approval

4 July 2017

HREC

Southern Health and Disability Ethics Committees, Wellington 6011 NZ

HREC Approval ID

17/STH/106

CTN

CT-2015-CTN–0180-0-v1

ANZCTR

ACTRN12618000208202

STUDY SITE

Zenith Technology Corp. Ltd - 156 Frederick Street, PO Box 1777, Dunedin, NZ

STATUS

Completed