Comparative assessment of the absorption of a single oral dose of beclomethasone dipropionate in healthy male and female volunteers with and without concurrent oral charcoal blockade.
- Registration Number
- ACTRN12614000990628
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Healthy male and non-pregnant females
Aged between 18 and 45
Non-smoker
BMI between 18.5 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, pulse, heart rate, temperature, well-being assessment and laboratory tests
Able to provide written informed consent
Any history of COPD, chronic bronchitis, emphysema, asthma , or any other lung disease, recent upper or lower respiratory tract infection, migraine headaches
Concomitant drug therapy of any kind
Who have taken any drug that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing
Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
Sensitivity to beclomethasone dipropionate any other similar class medicines or the excipients of beclomethasone dipropionate
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
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
Who are planning to start a family within 60 days of receiving the final dose.
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 beclomethasone dipropionate and 17-BMP (as summarised by Cmax and AUC) with and without concurrent oral charcoal. All plasma samples will be assayed for beclomethasone dipropionate using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. [0, 0.08, 0.025, 0.50, 0.75, 1, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 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, 0.08, 0.025, 0.50, 0.75, 1, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours ]