Comparative assessment of the absorption of a generic formulation of tibolone tablet against the innovator tibolone tablet conducted under fasting conditions in healthy female volunteers
- Conditions
- Bioequivalence study conducted in healthy volunteers comparing two formulations of tibolone 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, tibolone belongs to a class of medicines called synthetic steroid hormone drugs and is prescribed for the short-term treatment of symptoms due to natural or surgical menopause.Bioequivalence study conducted in healthy volunteers comparing two formulations of tibolone 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, tibolone belongs to a class of medicines called synthetic steroid hormone drugs and is prescribed for the short-term treatment of symptoms due to natural or surgical menopause.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12615000521527
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 30
Healthy Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33
Normal, healthy individuals as determined by medical history, physical examination, ECG, bood pressure and laboratory tests
Not currently using any prescribed hormonal contraceptive
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 depression, anxiety, obsessive-compulsive disorder, or post-traumatic stress syndrome
Pregnant, breast-feeding or have any obstetric or gynaecological conditions
Who have ever had an ectopic pregnancy
Who do not agree to using alternative forms of contraception or abstain from sexual activity during the study
Who have a history of breast cancer
With a history or family history of thrombophilia
Sensitivity to tibolone, any synthetic steroid medicines, excipients of tibolone
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who are lactose intolerant
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 tibolone (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for tibolone using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[0, 0.25, 0.5, 1.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.0 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, 1.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.25, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 20.0 and 24.0 hours]