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Trial registered on ANZCTR


Registration number
ACTRN12614000600640
Ethics application status
Approved
Date submitted
3/06/2014
Date registered
5/06/2014
Date last updated
24/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of fingolimod capsule against the innovator fingolimod capsule conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of fingolimod capsule in a 2 way crossover comparison against the innovator fingolimod capsule conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 284707 0
None
Universal Trial Number (UTN)
U1111-1157-1171
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 for 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.
292065 0
Condition category
Condition code
Other 292403 292403 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 (3 x 0.5 mg) 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.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing, dipstick drugs of abuse testing and an ECG 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 healthy of participants along with HIV, Hepatitis and drugs of abuse testing.
Intervention code [1] 289498 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] 292264 0
To compare the bioavailability of fingolimod and its active metabolite fingolimod-phosphate (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for fingolimod and fingolimod-phosphate using two fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 292264 0
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24, 32, 48, 56 and 72 hours post dosing
Secondary outcome [1] 308590 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] 308590 0
0, 1, 2, 3, 4, 5, 6, 7, 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
Gender
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
Who have receievd an investigational compound or drug known to induce or inhibit liver enqymes within 60 days of the start of the study
History or family history of depression or other mental illness, epilepsy or seizures
Who have a histroy of bleeding disorders or blood clotting problems
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
Who are lactose intolerant
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)
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.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced two-way crossover design.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6089 0
New Zealand
State/province [1] 6089 0
Otago

Funding & Sponsors
Funding source category [1] 289329 0
Commercial sector/Industry
Name [1] 289329 0
Alembic Pharmaceuticals Limited
Address [1] 289329 0
Alembic Road
Vadodara, Gujarat
390 003
Country [1] 289329 0
India
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 288017 0
None
Name [1] 288017 0
Address [1] 288017 0
Country [1] 288017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291097 0
Northern B Health & Disability Ethics Committee
Ethics committee address [1] 291097 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 291097 0
New Zealand
Date submitted for ethics approval [1] 291097 0
22/05/2014
Approval date [1] 291097 0
10/06/2014
Ethics approval number [1] 291097 0
14/NTB/70

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 3 x 0.5 mg against the reference formulation (innovator brand of 3 x 0.5 mg fingolimod capsule) following oral administration of a single dose of 3 x 0.5 mg in healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
Public notes

Contacts
Principal investigator
Name 48874 0
Dr Noelyn Hung
Address 48874 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 48874 0
New Zealand
Phone 48874 0
+6434779669
Fax 48874 0
+6434779605
Email 48874 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 48875 0
Mrs Linda Folland
Address 48875 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 48875 0
New Zealand
Phone 48875 0
+6434779669
Fax 48875 0
+6434779605
Email 48875 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 48876 0
Dr Tak Hung
Address 48876 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 48876 0
New Zealand
Phone 48876 0
+6434779669
Fax 48876 0
+6434779605
Email 48876 0
tak.hung@zenithtechnology.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary