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Trial registered on ANZCTR
Registration number
ACTRN12614000099628
Ethics application status
Approved
Date submitted
23/01/2014
Date registered
28/01/2014
Date last updated
13/10/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
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
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Scientific title
A single dose, randomized, blinded, bioequivalence study of 3 mg drospirenone /0.02 mg ethinyloestradiol tablets in a 2 way crossover comparison against the innovator drospirenone/ethinyloestradiol tablet conducted under fasting conditions in healthy female volunteers
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Secondary ID [1]
283971
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None
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Universal Trial Number (UTN)
U1111-1147-3022
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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).
290999
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Condition category
Condition code
Other
291343
291343
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single dose, crossover over study design whereby each participant receives the test formulation of drospirenone/ethinyloestradiol (1 x 3 mg/0.02 mg) on one occasion and the innovator formulation of drospirenone/ethinyloestradiol (1 x 3 mg/0.02 mg) on one occasion with each dose seperated by a two week washout period. The intervention for this trial is the test formulation of drospirenone/ethinyloestradiol.
Each dose (1 x 3/0.02 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 24 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.
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Intervention code [1]
288656
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Treatment: Drugs
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Comparator / control treatment
Single dose, crossover over study design whereby each participant receives the test formulation of drospirenone/ethinyloestradiol (1 x 3/0.02 mg) on one occasion and the innovator formulation of drospirenone/ethinyloestradiol (1 x 3/0.02 mg) on one occasion with each dose seperated by a two week washout period. The comparator/control for this trial is the innovator formulation of drospirenone/ethinyloestradiol.
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Control group
Active
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Outcomes
Primary outcome [1]
291336
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To compare the bioavailability of drospirenone/ethinyloestradiol (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for drospirenone/ethinyloestradiol using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
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Assessment method [1]
291336
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Timepoint [1]
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0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0, 48.0, 56.0 and 72.0 hours
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Secondary outcome [1]
306550
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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.
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Assessment method [1]
306550
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Timepoint [1]
306550
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0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0, 48.0, 56.0 and 72.0 hours
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Eligibility
Key inclusion criteria
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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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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.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Bio-equivalence
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/02/2014
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Actual
8/05/2014
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Date of last participant enrolment
Anticipated
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Actual
23/05/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5772
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New Zealand
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State/province [1]
5772
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Otago
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Funding & Sponsors
Funding source category [1]
288602
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Commercial sector/Industry
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Name [1]
288602
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Medigen Pharma Pty Ltd
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Address [1]
288602
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Level 26
530 Collins St
Melbourne
VIC 3000
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Country [1]
288602
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Zenith Technology Corp Ltd
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Address
156 Frederick St
Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
287312
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None
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Name [1]
287312
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Address [1]
287312
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Country [1]
287312
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290464
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
290464
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Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
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Ethics committee country [1]
290464
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New Zealand
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Date submitted for ethics approval [1]
290464
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29/08/2013
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Approval date [1]
290464
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02/09/2013
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Ethics approval number [1]
290464
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13/NTA/152
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Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of one 3 mg/0.02 mg drospirenone/ethinyloestradiol tablet relative to that of the reference formulation (innovator brand of 3 mg/0.02 mg drospirenone/ethinyloestradiol tablet) following oral administration of a single dose of 3 mg/0.02 mg in healthy female subjects under fasting conditions.
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Trial website
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Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
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Public notes
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Contacts
Principal investigator
Name
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Dr Noelyn Hung
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Address
45826
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Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
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Country
45826
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New Zealand
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Phone
45826
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+6434779669
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Fax
45826
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Email
45826
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[email protected]
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Contact person for public queries
Name
45827
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Mrs Linda Folland
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Address
45827
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Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
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Country
45827
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New Zealand
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Phone
45827
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+6434779669
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Fax
45827
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Email
45827
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[email protected]
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Contact person for scientific queries
Name
45828
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Dr Cheung-Tak Hung
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Address
45828
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Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
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Country
45828
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New Zealand
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Phone
45828
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+6434779669
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Fax
45828
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Email
45828
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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