None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 2.5 mg tibolone tablet relative to that of the reference formulation (innovator brand of 2.5 mg tibolone tablet) following oral administration of a single dose of 2.5 mg in healthy female subjects under fasting conditions.
Interventions
Single dose, crossover over study design whereby each participant receives the test formulation of tibolone (1 x 2.5 mg) on one occasion and the innovator formulation of tibolone (1 x 2.5 mg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of tibolone. Each dose (1 x 2.5 mg) will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance can be monitored and for 28 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the healthy of participants along with HIV, Hepatitis and drugs of abuse testing.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy 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 contraceptive Able to provide written informed consent
Exclusion criteria
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.
Outcome results
None listed