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Trial registered on ANZCTR
Registration number
ACTRN12615001251516
Ethics application status
Approved
Date submitted
12/11/2015
Date registered
16/11/2015
Date last updated
30/08/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of buprenorphine transdermal patch against the innovator buprenorphine transdermal patch conducted under fasting conditions with the inclusion of a naltrexone block in healthy male and female volunteers
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Scientific title
A single dose, randomized, open label, bioequivalence study of a test formulation of buprenorphine transdermal patch in a 2 way crossover comparison against the innovator buprenorphine transdermal patch conducted under fasting conditions with the inclusion of a naltrexone block in healthy male and female volunteers
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Secondary ID [1]
287861
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None
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Universal Trial Number (UTN)
U1111-1175-3382
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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 buprenorphine transdermal patch 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, buprenorphine is a partial opioid agonist indicated for the management of moderate to severe pain.
296750
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Condition category
Condition code
Other
296981
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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 study design whereby each participant receives the test formulation of buprenorphine (1 x 20 mcg/hr) on one occasion and the innovator formulation of buprenorphine (1 x 20 mcg/hr) on one occasion with the inclusion of a naltrexone block given prior to patch application, at application and every 12 hours up until 168 hours post dosing. Each naltrexone dose will be 50 mg. Each buprenorphine dosing will be seperated by a two week washout period. The intervention for this trial is the test formulation of buprenorphine .
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 12 hours prior to dosing to ensure compliance and will 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 12 hours prior to dosing.
Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing.
Each buprenorphine patch will be applied to the upper arm. Investigators will examine every subject to ensure the patch has been applied correctly.
Each dose of naltrexone 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.
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Intervention code [1]
293237
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Treatment: Drugs
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Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of buprenorphine (1 x 20 mcg/hr) on one occasion and the innovator formulation of buprenorphine (1 x 20 mcg/hr) on one occasion with each dose seperated by a two week washout period. The comparator/control for this trial is the innovator formulation of buprenorphine .
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare the bioavailability of buprenorphine (as summarised by Cmax and AUC). All plasma samples will be assayed for buprenorphine using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
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Assessment method [1]
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Timepoint [1]
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0, 6, 10, 12, 18, 24, 36, 48, 50, 72, 84, 96, 108, 120, 132, 144, 156, 168, 176, 192, 200, 216, 224, 240 and 264 hours
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Secondary outcome [1]
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Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
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Assessment method [1]
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Timepoint [1]
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0, 6, 10, 12, 18, 24, 36, 48, 50, 72, 84, 96, 108, 120, 132, 144, 156, 168, 176, 192, 200, 216, 224, 240 and 264 hours
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Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
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
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to buprenorphine or any other similar class of medicines, or the excipients of buprenorphine
Sensitivity to naltrexone or any other similar class of medicines, or the excipients of naltrexone
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
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
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
23/11/2015
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Actual
26/01/2016
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Date of last participant enrolment
Anticipated
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Actual
12/02/2016
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Date of last data collection
Anticipated
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Actual
27/04/2016
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Sample size
Target
32
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Accrual to date
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Final
33
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Juno Pharmaceuticals Pty Ltd
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Address [1]
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Level 3, 9 Yarra Street
South Yarra
VIC 3141
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Country [1]
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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
PO Box 1777
Dunedin 9054
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
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Ethics committee country [1]
293837
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New Zealand
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Date submitted for ethics approval [1]
293837
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Approval date [1]
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08/11/2015
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Ethics approval number [1]
293837
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15/CEN/170
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Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 20 mcg/hr against the reference formulation (innovator brand of 1 x 20 mcg/hr buprenorphine transdermal patch) following oral administration of a single dose of 20 mcg/hr with the inclusion of a naltrexone block in healthy male and 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
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Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
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+6434779669
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Fax
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+6434779605
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Linda Folland
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Address
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Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
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+6434779669
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Fax
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+6434779605
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Email
61483
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[email protected]
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Contact person for scientific queries
Name
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Dr Cheung-Tak Hung
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Address
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Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
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Country
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New Zealand
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Phone
61484
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+6434779669
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Fax
61484
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+6434779605
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Email
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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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