Comparative assessment of the absorption of a generic formulation of 3 mg drospirenone /0.02 mg ethinyloestradiol tablet against the innovator drospirenone/ethinyloestradiol tablet conducted under fasting conditions in healthy female volunteers
- Conditions
- Bioequivalence study conducted in healthy volunteers comparing two formulations of drospirenone/ethinyloestradiol 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, drospirenone and ethinyloestradiol is a combined oral contraceptive contained synthetic progestogen (drospirenone) and the synthetic oestrogen (ethinyloestradiol).Bioequivalence study conducted in healthy volunteers comparing two formulations of drospirenone/ethinyloestradiol 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, drospirenone and ethinyloestradiol is a combined oral contraceptive contained synthetic progestogen (drospirenone) and the synthetic oestrogen (ethinyloestradiol).Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12614000099628
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 24
Healthy 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
Not currently using any prescribed hormonal contraceptives
Able to provide written informed consent
Males
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
History of alcohol or drug abuse or dependency
Smoker (anyone who has smoked in the last 6 months)
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Who are pregnant, breastfeeding or who have any obstetric or gynaecological condition
Who have ever had an ectopic pregnancy or have a history or family history of thrombophilia or breast cancer
Sensitivity to drospirenone/ethinyloestradiol, any contraceptive agents, excipients of drospirenone/ethinyloestradiol
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