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Trial registered on ANZCTR


Registration number
ACTRN12616000498493
Ethics application status
Approved
Date submitted
14/04/2016
Date registered
18/04/2016
Date last updated
30/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of imatinib tablet against the innovator imatinib tablet conducted under fed conditions in healthy male volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of imatinib tablet in a 2 way crossover comparison against the innovator imatinib tablet conducted under fed conditions in healthy male volunteers
Secondary ID [1] 288997 0
None
Universal Trial Number (UTN)
U1111-1180-9405
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukaemia 298403 0
Blood disorders 298421 0
Cancer 298422 0
Condition category
Condition code
Cancer 298501 298501 0 0
Leukaemia - Chronic leukaemia
Cancer 298517 298517 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of imatinib (1 x 400 mg) on one occasion and the innovator formulation of imatinib (1 x 400 mg) on one occasion with each dose seperated by a two week washout period. The intervention for this trial is the test formulation of imatinib.

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 receiving breakfast. Subjects will be provided with a standardised high fat breakfast which they must start eating 30 minutes 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.

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. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 294484 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of imatinib (1 x 400 mg) on one occasion and the innovator formulation of imatinib (1 x 400 mg) on one occasion with each dose seperated by a two week washout period. The comparator/control for this trial is the innovator formulation of imatinib.
Control group
Active

Outcomes
Primary outcome [1] 297994 0
To compare the bioavailability of imatinib (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for imatinib using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 297994 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56 & 72 hours post dosing.
Secondary outcome [1] 322856 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] 322856 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56 & 72 hours post dosing.

Eligibility
Key inclusion criteria
Healthy male
Aged between 18 and 55
Non-smoker
BMI between 18 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
Gender
Males
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 imatinib or any other similar class of medicines, or the excipients of imatinib
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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] 7813 0
New Zealand
State/province [1] 7813 0
Otago

Funding & Sponsors
Funding source category [1] 293357 0
Commercial sector/Industry
Name [1] 293357 0
Natco Pharma Australia Pty Ltd
Address [1] 293357 0
Level 1
313 Burwood Road
Hawthorn VIC 3122
Country [1] 293357 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] 292183 0
None
Name [1] 292183 0
Address [1] 292183 0
Country [1] 292183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294823 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 294823 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 294823 0
New Zealand
Date submitted for ethics approval [1] 294823 0
22/03/2016
Approval date [1] 294823 0
05/04/2016
Ethics approval number [1] 294823 0
16/NTB/60

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 400 mg imatinib tablet against the reference formulation (innovator brand of 1 x 400 mg imatinib tablet) following oral administration of a single dose of 400 mg in healthy male subjects under fed 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 65158 0
Dr Noelyn Hung
Address 65158 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 65158 0
New Zealand
Phone 65158 0
+6434779669
Fax 65158 0
+6434779605
Email 65158 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 65159 0
Mrs Linda Folland
Address 65159 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 65159 0
New Zealand
Phone 65159 0
+6434779669
Fax 65159 0
+6434779605
Email 65159 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 65160 0
Dr Tak Hung
Address 65160 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 65160 0
New Zealand
Phone 65160 0
+6434779669
Fax 65160 0
+6434779605
Email 65160 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