None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 325mg ferrous sulfate controlled release tablet against the reference formulation (innovator brand of 1 x 325mg ferrous sulfate controlled release tablet) following oral administration of a single dose of 1 x 325mg in healthy male subjects under fasting conditions with diet control.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of ferrous sulfate (1 x 325mg) on one occasion and the innovator formulation of ferrous sulfate (1 x 325mg) 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.
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
Single dose, crossover study design whereby each participant receives the test formulation of ferrous sulfate (1 x 325mg) on one occasion and the innovator formulation of ferrous sulfate (1 x 325mg) 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. 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.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 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 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
Outcome results
None listed