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Comparative assessment of the absorption of a generic formulation of vorizonazole tablet against the innovator vorizonazole tablet conducted under fasting conditions in healthy male and female volunteers

Phase 1
Completed
Registration Number
ACTRN12614000250639
Lead Sponsor
Zenith Technology Corporation Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria

Healthy males and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 19 and 30
Normal, healthy individuals as determined by medical history, physical examination, ECG, bood 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 excluding prescribed hormonal contraceptives
Who have receievd an investigational compound or drug known to induce or inhibit liver enqymes within 60 days of the start of the study
History or family history of depression or other mental illness, epilepsy or seizures
Sensitivity to voriconazole, any other triazole antifungal medicines, excipients of voriconazole
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who are lactose intolerant
Females who are breastfeeding or are planning to start a family within 60 days of dosing
Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
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
NameTimeMethod
To compare the bioavailability of voriconazole (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for voriconazole using a 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, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24 and 32 hours ]
Secondary Outcome Measures
NameTimeMethod
Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. [0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24 and 32 hours ]
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