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Trial registered on ANZCTR


Registration number
ACTRN12618001695291
Ethics application status
Approved
Date submitted
11/10/2018
Date registered
15/10/2018
Date last updated
15/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of ferrous sulfate/folic acid modified release tablet against the innovator ferrous sulfate/folic acid modified release tablet conducted under fasting conditions with diet control in healthy male volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of ferrous sulfate/folic acid modified release tablet in a 2 way crossover comparison against the innovator ferrous sulfate/folic acid modified release tablet conducted under fasting conditions with diet control in healthy male volunteers
Secondary ID [1] 296313 0
None
Universal Trial Number (UTN)
U1111-1205-8582
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency.

Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, ferrous sulfate is an iron supplement indicated for the prevention and treatment of iron deficiency
310024 0
Condition category
Condition code
Blood 308777 308777 0 0
Anaemia
Diet and Nutrition 308778 308778 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of ferrous sulfate/folic acid (1 x 250 mg /300 mcg) on one occasion and the innovator formulation of ferrous sulfate/folic acid (1 x 250 mg /300 mcg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of ferrous sulfate/folic acid.

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 for 24 hours after dosing.

Standard low iron and low fat meals will be consumed at the Clinical Site with no additional food intake allowed. The meal plan has been designed by a Nutritionist with daily iron content approximately 7mg and fat content approximately 16-21% of total energy per day. 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] 312643 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of ferrous sulfate/folic acid (1 x 250mg/300 mg) on one occasion and the innovator formulation of ferrous sulfate/folic acid (1 x 250mg/300 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 ferrous sulfate/folic acid.
Control group
Active

Outcomes
Primary outcome [1] 307756 0
To compare the bioavailability of ferrous sulfate/folic acid (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for ferrous sulfate using one fully validated colorimetric method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 307756 0
-2, -1, -0.5, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, 24 and 36 hours post dosing
Secondary outcome [1] 352794 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] 352794 0
-2, -0.5, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, 24 and 36 hours post dosing

Eligibility
Key inclusion criteria
Healthy males
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
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to ferrous sulfate, sodium ascorbate or any other similar class of medicines, or the excipients of ferrous sulfate
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
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] 20932 0
New Zealand
State/province [1] 20932 0
Otago

Funding & Sponsors
Funding source category [1] 300909 0
Commercial sector/Industry
Name [1] 300909 0
Neo Health (OTC) Pty Ltd
Address [1] 300909 0
3 Lydham Place
Castle Hill
NSW 2154
Country [1] 300909 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] 300474 0
None
Name [1] 300474 0
Address [1] 300474 0
Country [1] 300474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301678 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 301678 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 301678 0
New Zealand
Date submitted for ethics approval [1] 301678 0
28/11/2017
Approval date [1] 301678 0
19/12/2017
Ethics approval number [1] 301678 0
17/NTA/256

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 250 mg ferrous sulfate/300 mcg folic acid modified release tablet against the reference formulation (innovator brand of 1 x 250 mcg ferrous sulfate/300 mcg folic acid modified release tablet ) following oral administration of a single dose of 1 x 250mg/300 mcg in healthy male subjects under fasting conditions with diet control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87758 0
Dr Noelyn Hung
Address 87758 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 87758 0
New Zealand
Phone 87758 0
+6434779669
Fax 87758 0
+6434779605
Email 87758 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 87759 0
Mrs Linda Folland
Address 87759 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 87759 0
New Zealand
Phone 87759 0
+6434779669
Fax 87759 0
+6434779605
Email 87759 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 87760 0
Dr Tak Hung
Address 87760 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 87760 0
New Zealand
Phone 87760 0
+6434779669
Fax 87760 0
+6434779605
Email 87760 0
tak.hung@zenithtechnology.co.nz

No information has been provided regarding IPD availability
Summary results
No Results