Comparative assessment of the absorption of a generic formulation of imatinib tablet against the innovator imatinib tablet conducted under fed conditions in healthy male volunteers

Phase 1

Completed

• Conditions: eukaemia; Blood disorders; Cancer; Leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Stomach

• Registration Number: ACTRN12616000498493
• Lead Sponsor: Zenith Technology Corp Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the bioavailability of imatinib (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for imatinib using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56 & 72 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.[0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56 & 72 hours post dosing.]