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

Phase 1

Completed

• Conditions: 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; 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; Blood - Anaemia; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12618001695291
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-15
• Study Completion: 2018-12-13
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 22

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[ -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 Measures

Name	Time	Method
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.[ -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]