None listed
Conditions
Brief summary
The objective of this study is to compare the pharmacokinetic parameters of the test (new) formulation of 53858-86-9 tablet in a 2 way crossover comparison against the innovator 53858-86-9 tablet conducted in participants under fed conditions with diet control. In lay terms the purpose of our study is to compare how two formulations of 53858-86-9 are handled in the body after taking a test and reference (innovator) tablet on one occasion each after consuming a high fat/low iron breakfast and having a controlled diet throughout the entire study.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of 53858-86-9 370 mg tablet on one occasion and the innovator formulation of 53858-86-9 370 mg tablet on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of 53858-86-9.
The duration of the study is approximately 5 weeks comprising up to 3 weeks for screening, two 2-day sampling periods, a minimum of 1 week washout and 1 day study
Single dose, crossover study design whereby each participant receives the test formulation of 53858-86-9 370 mg tablet on one occasion and the innovator formulation of 53858-86-9 370 mg tablet on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of 53858-86-9. The duration of the study is approximately 5 weeks comprising up to 3 weeks for screening, two 2-day sampling periods, a minimum of 1 week washout and 1 day study exit procedures. Screening and study exit procedures will take place at an outpatient facility and each clinical period will involve confinement at the Clinical Site. Participants will be required to consume a controlled diet throughout both study periods. All food will be supplied for consumption at home and at the clinical site. Breakfast will be consumed at the Clinical Site prior to dosing in both study periods. The diet will consist of daily intake of protein: 122.9; fat: 81g; carbs: 243.6g; iron: 8.8mg. This is approximate only and may vary slightly each day. Each dose will be taken orally with 240 ml of water at ambient temperature immediately following a standardised breakfast. 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
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Participants presenting with low ferritin, normal haemoglobin Aged between 18 and 55 Non-smoker BMI between 18.5 and 32.0 inclusive Able to consume a controlled diet Healthy individuals as determined by medical history, physical examination, electrocardiogram (ECG), blood pressure and laboratory tests Able to provide written informed consent
Exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches Any history of haemochromatosis. An expectation of menstruation during the dose administration and sample collection periods Concomitant drug therapy of any kind Sensitivity to 53858-86-9 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 Difficulty with swallowing whole tablets or poor venous access 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
Outcome results
None listed