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Trial registered on ANZCTR


Registration number
ACTRN12613000799752
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
17/07/2013
Date last updated
10/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
A single dose, randomized, blinded, bioequivalence study of tibolone tablets in a 2 way crossover comparison against the innovator tibolone tablet conducted under fasting conditions in healthy female volunteers
Secondary ID [1] 282799 0
None
Universal Trial Number (UTN)
U1111-1144-3298
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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.
289570 0
Condition category
Condition code
Other 289899 289899 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287482 0
Treatment: Drugs
Comparator / control treatment
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 comparator/control for this trial is the innovator formulation of tibolone.
Control group
Active

Outcomes
Primary outcome [1] 289959 0
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.
Timepoint [1] 289959 0
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, 24.0 and 28.0 hours
Secondary outcome [1] 303662 0
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.
Timepoint [1] 303662 0
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, 24.0 and 28.0 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All formulations will be labelled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.

Each participant will be identified by a 3 digit screening number and a 2 digit subject number. the screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced two-way crossover design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5170 0
New Zealand
State/province [1] 5170 0
Otago

Funding & Sponsors
Funding source category [1] 287576 0
Commercial sector/Industry
Name [1] 287576 0
Medigen Pharma Pty Ltd
Address [1] 287576 0
Level 26
530 Collins St
Melbourne
VIC 3000
Country [1] 287576 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 286326 0
None
Name [1] 286326 0
Address [1] 286326 0
Country [1] 286326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289551 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 289551 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 289551 0
New Zealand
Date submitted for ethics approval [1] 289551 0
25/06/2013
Approval date [1] 289551 0
18/07/2013
Ethics approval number [1] 289551 0
13/CEN/86

Summary
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.
Trial website
Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
Public notes

Contacts
Principal investigator
Name 41290 0
Dr Noelyn Hung
Address 41290 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 41290 0
New Zealand
Phone 41290 0
+6434779669
Fax 41290 0
Email 41290 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 41291 0
Mrs Linda Folland
Address 41291 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 41291 0
New Zealand
Phone 41291 0
+6434779669
Fax 41291 0
Email 41291 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 41292 0
Dr Cheung-Tak Hung
Address 41292 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 41292 0
New Zealand
Phone 41292 0
+6434779669
Fax 41292 0
Email 41292 0
tak.hung@zenithtechnology.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary