Comparative assessment of the absorption of a generic formulation of anagrelide capsule against the innovator anagrelide capsule conducted under fasting conditions in healthy male and female volunteers
- Conditions
- Bioequivalence study conducted in healthy volunteers comparing two formulations of anagrelide with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, anagrelide is a platelet-reducing agent . It is used to decrease the risk of blood clots in patients who have thrombocythaemia (too many platelets in the blood). It works to decrease production of platelets in the blood..Bioequivalence study conducted in healthy volunteers comparing two formulations of anagrelide with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, anagrelide is a platelet-reducing agent . It is used to decrease the risk of blood clots in patients who have thrombocythaemia (too many platelets in the blood). It works to decrease production of platelets in the blood..Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12615001084572
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 23
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to anagrelide or any other similar class of medicines, or the excipients of anagrelide
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
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 anagrelide (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for anagrelide using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7 and 8 hours]
- 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, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7 and 8 hours]