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.
- Conditions
- Iron DificiencyBlood - AnaemiaDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12623000530628
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[ 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 Measures
Name Time Method 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.[ 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.]