Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000530628
Ethics application status
Approved
Date submitted
12/05/2023
Date registered
19/05/2023
Date last updated
19/05/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of Iron Polymaltose tablet against the innovator Maltofer tablet conducted in iron deficient participants under fed conditions with diet control.
Scientific title
A single dose, randomized, double-blind, bioavailability pilot study of a test formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide tablet in a 2 way crossover comparison against the innovator iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide tablet conducted in iron deficient participants under fed conditions with diet control.
Secondary ID [1] 309635 0
None
Universal Trial Number (UTN)
U1111-1291-4228
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Dificiency 329967 0
Condition category
Condition code
Blood 326873 326873 0 0
Anaemia
Diet and Nutrition 326874 326874 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover pilot study design whereby each participant receives the test formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide 370mg tablet on one occasion and the innovator formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide 370mg tablet on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide.

Each dose is separated by a one week washout period.

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 a low fat / low iron content breakfast 30 minutes prior to dosing 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 12 hours prior to dosing to ensure compliance and will be monitored for 24 hours after dosing.

For a period of 7 days prior to dose administration in period 1, until 36 hours after dose administration in period 2, participant’s food intake will be controlled with a diet low in iron and fat (16 days in total). All meals and snacks will be reviewed for nutritional balance (using appropriate levels of protein, fat and carbohydrate) and all food will be supplied to participants to consume either at home during the pre-study run in and washout period, and at the Clinical Site during the confinement periods.

The meal plan has been designed by a Dietician and the low fat / low iron breakfast on study days 8 and 15 consist of a total calorie content of 462.46 kcal and Iron content of 0.84 mg. The daily standard meals composition will be determined by the dietician prior to the study commencing.

Alcohol breath testing and urine drugs of abuse testing and urine pregnancy testing (participants of childbearing potential only) will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing.

Pre and post study laboratory tests and procedures 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] 326066 0
Treatment: Drugs
Comparator / control treatment
The comparator/control for this trial is the innovator formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide.
Control group
Active

Outcomes
Primary outcome [1] 334718 0
To compare the bioavailability of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide (as summarised by Cmax and AUC) for the formulation. All serum samples will be assayed for iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide using one fully validated colorimetric method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 334718 0
Pre-dose blood samples will be collected at -2, -0.5 and 0 hours and post-dose samples will be collected at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, 24 and 36 hours.
Secondary outcome [1] 421860 0
Time to maximum peak concentration (Tmax) will be determined by serum sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 421860 0
Pre-dose blood samples will be collected at -2, -0.5 and 0 hours and post-dose samples will be collected at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, 24 and 36 hours.

Eligibility
Key inclusion criteria
Participants with a ferritin result <30ug/L
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 32.0 inclusive
Able to consume a low-iron diet for a period of 16 days.
Females who are within 2 days of their menstruation or on hormonal contraceptives and able to control the timing of their menstrual cycle throughout the study.
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?
No
Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Any history of iron-overload
Concomitant drug therapy of any kind
Sensitivity to iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide or any other similar class of medicines, or any excipients in either formulation.
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 30 days of the start of the study or donated blood in the 30 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, the Section Head - Trials and Regulatory Affairs. or their delegates. The Trial Physician and Principal Investigator are completely blinded and do not know what treatments are allocated to each subject who has been deemed eligible for participation. Allocation concealment to each formulation is completed by central randomisation by computer.
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. Allocation of the subject number is completed by simple randomisation using a randomisation table created by computer software.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 25494 0
New Zealand
State/province [1] 25494 0
Otago

Funding & Sponsors
Funding source category [1] 313822 0
Commercial sector/Industry
Name [1] 313822 0
Nova Chem Australasia Pty Ltd
Country [1] 313822 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
North Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 315656 0
None
Name [1] 315656 0
Address [1] 315656 0
Country [1] 315656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312978 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 312978 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 312978 0
New Zealand
Date submitted for ethics approval [1] 312978 0
30/03/2023
Approval date [1] 312978 0
08/05/2023
Ethics approval number [1] 312978 0
2023 FULL 16692

Summary
Brief summary
The objective of this study is to compare the pharmacokinetic parameters of the test (new) formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide tablet in a 2 way crossover comparison against the innovator iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide tablet conducted in iron deficient participants under fed conditions with diet control to determine the number of participants required in a pivotal study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126562 0
Dr Noelyn Hung
Address 126562 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 126562 0
New Zealand
Phone 126562 0
+64 21 482 148
Fax 126562 0
+64 3 477 9605
Email 126562 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 126563 0
Ms Linda Folland
Address 126563 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 126563 0
New Zealand
Phone 126563 0
+64 3 477 9669
Fax 126563 0
+64 3 477 9605
Email 126563 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 126564 0
Dr Tak Hung
Address 126564 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 126564 0
New Zealand
Phone 126564 0
+64 3 477 9669
Fax 126564 0
+64 3 477 9605
Email 126564 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


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.