Comparative assessment of the absorption of a generic formulation of 600 mg imatinib tablet against the innovator imatinib tablet conducted under fed conditions in healthy male volunteers
A single dose, randomized, blinded, bioequivalence study of a test formulation of imatinib tablet in a 3 way crossover comparison against the innovator imatinib tablets conducted under fed conditions in healthy male volunteers
Zenith Technology Corp Ltd
24 participants
Jul 22, 2017
Interventional
Conditions
Summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 600 mg imatinib tablet against the reference formulation 1 (innovator brand of 1 x 400 mg and 2 x 100 mg imatinib tablet) and the reference formulation 2 (innovator brand of 1 x 400 mg and 2 x 100 mg imatinib tablet) following oral administration of a single dose of 600 mg in healthy male subjects under fed conditions.
Eligibility
Inclusion Criteria6
- Healthy male
- Aged between 18 and 55
- Non-smoker
- BMI between 18 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 Criteria8
- Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
- Concomitant drug therapy of any kind
- Sensitivity to imatinib or any other similar class of medicines, or the excipients of imatinib
- 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
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Interventions
Single dose, crossover study design whereby each participant receives the test formulation of imatinib (1 x 600 mg) on one occasion, the innovator formulation of imatinib (formulation 1) (1 x 400 mg and 2 x 100 mg) on one occasion and the innovator formulation of imatinib (formulation 2) (1 x 400 mg and 2 x 100 mg) on one occasion with each dose seperated by a two week washout period. The intervention for this trial is the test formulation of imatinib. 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 prior to receiving breakfast. Subjects will be provided with a standardised high fat breakfast which they must start eating 30 minutes prior to dosing. Subjects are required 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. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. 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.
Locations(1)
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ACTRN12617000740392