Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000208202
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
9/02/2018
Date last updated
14/07/2024
Date data sharing statement initially provided
14/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of atorvastatin oral spray against the innovator atorvastatin capsule conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, open label, pilot study of a test formulation of atorvastatin oral spray in a 2 way crossover comparison against the innovator atorvastatin capsule conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 293912 0
None
Universal Trial Number (UTN)
U1111-1198-4268
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pilot pharmacokinetic study conducted in healthy volunteers comparing two formulations of atorvastatin (oral spray and capsule) with no health condition or problem studied.

Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, atorvastatin is used as an adjunct to diet for the treatment of patients with hypercholesterolaemia. 306392 0
Condition category
Condition code
Blood 305479 305479 0 0
Other blood disorders
Metabolic and Endocrine 305593 305593 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, two sequence, crossover study design whereby each participant receives the test formulation of atorvastatin oral spray (1 x 8 mg) on one occasion and the innovator formulation of atorvastatin oral capsule (1 x 20 mg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of atorvastatin.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose).

Participants are required not to eat for 10 hours prior to dosing. Subjects are required to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for adverse events for 24 hours after dosing.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing.

Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing.

Each dose will be taken orally with 240 ml of water at ambient temperature. A mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 300182 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover pilot study design whereby each participant receives the test formulation of atorvastatin oral spray (1 x 8 mg) on one occasion and the innovator formulation of atorvastatin capsule (1 x 20 mg) on one occasion with each dose seperated by a one week washout period. The comparator/control for this trial is the innovator formulation of atorvastatin.
Control group
Active

Outcomes
Primary outcome [1] 304618 0
To compare the relative bioavailability of atorvastatin (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for atorvastatin using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 304618 0
0, 2 min, 5 min, 15 min, 30 min, 45 min and at 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 32, 48 and 56 hours post dosing
Secondary outcome [1] 342559 0
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 342559 0
0, 2 min, 5 min, 15 min, 30 min, 45 min and at 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 32, 48 and 56 hours post dosing

Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All formulations will be labelled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study. Sequence generation will be by using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2018
Actual
29/09/2018
Date of last participant enrolment
Anticipated
Actual
29/09/2018
Date of last data collection
Anticipated
Actual
8/10/2018
Sample size
Target
10
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 9538 0
New Zealand
State/province [1] 9538 0
Otago

Funding & Sponsors
Funding source category [1] 298537 0
Commercial sector/Industry
Name [1] 298537 0
Medlab Clinical Ltd
Country [1] 298537 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 297684 0
None
Name [1] 297684 0
Address [1] 297684 0
Country [1] 297684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299511 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 299511 0
Ethics committee country [1] 299511 0
New Zealand
Date submitted for ethics approval [1] 299511 0
28/06/2017
Approval date [1] 299511 0
28/07/2017
Ethics approval number [1] 299511 0
17/STH/106

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80666 0
Dr Noelyn Hung
Address 80666 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 80666 0
New Zealand
Phone 80666 0
+6434779669
Fax 80666 0
+6434779605
Email 80666 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 80667 0
Linda Folland
Address 80667 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 80667 0
New Zealand
Phone 80667 0
+6434779669
Fax 80667 0
+6434779605
Email 80667 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 80668 0
Tak Hung
Address 80668 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 80668 0
New Zealand
Phone 80668 0
+6434779669
Fax 80668 0
+6434779605
Email 80668 0
tak.hung@zenithtechnology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.