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Trial registered on ANZCTR


Registration number
ACTRN12615001055594
Ethics application status
Approved
Date submitted
25/09/2015
Date registered
7/10/2015
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative bioequivalence study of a generic formulation of fingolimod capsule against the innovator fingolimod capsule in fasting healthy subjects
Scientific title
A single dose, randomized, blinded, two-period comparative bioequivalence study of a test formulation of fingolimod capsule against the innovator fingolimod capsule conducted under fasting conditions in healthy subjects
Secondary ID [1] 287541 0
None
Universal Trial Number (UTN)
U1111-1174-1198
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers comparing two formulations of fingolimod 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, fingolimod belongs to a class of medicines called asphingosine 1-phosphate modulators. It it used in the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. 296308 0
Condition category
Condition code
Other 296585 296585 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of fingolimod (3 x 0.5 mg) on one occasion and the innovator formulation of fingolimod (3 x 0.5 mg) on one occasion with each dose seperated by a six week washout period. The intervention for this trial is the test formulation of fingolimod.

Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.

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 before receiving each dose and 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 and for 24 hours after dosing.

Screening (pre study) and post study laboratory tests will be completed to assess the health of participants.
Intervention code [1] 292939 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of fingolimod (3 x 0.5 mg) on one occasion and the innovator formulation of fingolimod (3 x 0.5 mg) on one occasion with each dose seperated by a six week washout period. The comparator/control for this trial is the innovator formulation of fingolimod.
Control group
Active

Outcomes
Primary outcome [1] 296195 0
To compare the bioavailability of fingolimod (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for fingolimod using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 296195 0
0, 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post dosing
Secondary outcome [1] 317768 0
Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant.
Timepoint [1] 317768 0
0, 1, 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post dosing

Eligibility
Key inclusion criteria
Healthy males and non-pregnant females
Aged between 18 and 45
Non-smoker
BMI between 18 and 25 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
45 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 excluding prescribed hormonal contraceptives
Sensitivity to fingolimod any other similar class medicines, excipients of fingolimod
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who have any eye problems or conditions especially inflammation of the eye
Who have had a clinical illness within 4 weeks prior to the start of the study
Who have received any vaccinations within 1 month prior to dosing
Females who are breastfeeding or are planning to start a family within 60 days of dosing
Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
Smoker (anyone who has smoked in the last 6 months)
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. Randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generator).
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
Masking / blinding
Blinded (masking 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
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/10/2015
Actual
13/10/2015
Date of last participant enrolment
Anticipated
4/11/2015
Actual
7/12/2015
Date of last data collection
Anticipated
Actual
2/02/2016
Sample size
Target
26
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 7183 0
New Zealand
State/province [1] 7183 0
Otago

Funding & Sponsors
Funding source category [1] 292103 0
Commercial sector/Industry
Name [1] 292103 0
Novotech (Australia) Pty Limited
Country [1] 292103 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 290780 0
None
Name [1] 290780 0
Address [1] 290780 0
Country [1] 290780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293589 0
Central Health & Disability Ethics Committee
Ethics committee address [1] 293589 0
Ethics committee country [1] 293589 0
New Zealand
Date submitted for ethics approval [1] 293589 0
10/09/2015
Approval date [1] 293589 0
01/10/2015
Ethics approval number [1] 293589 0
15/CEN/146

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

Contacts
Principal investigator
Name 60590 0
Dr Noelyn Hung
Address 60590 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 60590 0
New Zealand
Phone 60590 0
+6434779669
Fax 60590 0
+6434779605
Email 60590 0
[email protected]
Contact person for public queries
Name 60591 0
Linda Folland
Address 60591 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 60591 0
New Zealand
Phone 60591 0
+6434779669
Fax 60591 0
+6434779605
Email 60591 0
[email protected]
Contact person for scientific queries
Name 60592 0
Cheung Tak Hung
Address 60592 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 60592 0
New Zealand
Phone 60592 0
+6434779669
Fax 60592 0
+6434779605
Email 60592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes


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.