Comparative assessment of the absorption of two generic formulations of doxycycline delayed release capsule against the innovator doxycycline delayed release tablet conducted under fasting conditions in healthy male and female volunteers
- Conditions
- Pilot bioequivalence study conducted in healthy volunteers comparing three formulations of doxycycline 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, doxycycline belongs to a class of medicines called a tetracyclines that are used to treat a wide range of organisms and work by killing or stopping the growth of bacteria, which cause infections or make acne worse.Pilot bioequivalence study conducted in healthy volunteers comparing three formulations of doxycycline 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, doxycycline belongs to a class of medicines called a tetracyclines that are used to treat a wide range of organisms and work by killing or stopping the growth of bacteria, which cause infections or make acne worse.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12614000267651
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
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, 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 excluding prescribed hormonal contraceptives
Used substances known to be strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erthyomycin, fluconazle and ketoconazole) or strong inducers of CYP enyzmes (such as barbiturates, carbamazepine, glucocortcoids, phenytoin and rifampin) within 28 days of study starts
Sensitivity to doxycycline, any tetracyclines or other antibiotic medicines, excipients of doxycycline
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are breastfeeding or are planning to start a family within 60 days of dosing
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 pharmacokinetic of doxycycline (as summarised by Cmax and AUC) for the three formulations. All plasma samples will be assayed for doxcycline using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. It is unlikely however that bioequivalence of the test and reference formulations will be demonstrated with twelve participants. However, data obtained in this study will provide valuable information in the design of the pivotal bioequivalence study.[0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours]
- Secondary Outcome Measures
Name Time Method 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, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours ]