Comparative assessment of the absorption of a generic formulation of metoprolol tablet against the innovator metoprolol tablet conducted under fasting conditions in healthy male and female volunteers
- Conditions
- Pilot bioequivalence study conducted in healthy volunteers comparing two formulations of metoprolol 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, metoprolol belongs to a class of medicines called beta-selective adrenoceptor blocking agent for the treatment of hypertension, angina pectoris and heart failure.Pilot bioequivalence study conducted in healthy volunteers comparing two formulations of metoprolol 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, metoprolol belongs to a class of medicines called beta-selective adrenoceptor blocking agent for the treatment of hypertension, angina pectoris and heart failure.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12613001128785
- 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, bood 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
Who have a history chest complaints, heart conditions or a very slow heart beats or uneven heart beat
Sensitivity to metoprolol, any beta-blocker medicines, excipients of metoprolol
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
- Secondary Outcome Measures
Name Time Method