Trial Review

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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
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
Secondary ID [1] 287861 0
None
Universal Trial Number (UTN)
U1111-1175-3382
Trial acronym
Linked study record

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 0
Condition category
Condition code
Other 296981 296981 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 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.
Intervention code [1] 293237 0
Treatment: Drugs
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 .
Control group
Active

Outcomes
Primary outcome [1] 296587 0
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.
Timepoint [1] 296587 0
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
Secondary outcome [1] 318808 0
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.
Timepoint [1] 318808 0
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

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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
Open (masking not used)
Who is / are masked / blinded?



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
23/11/2015
Actual
26/01/2016
Date of last participant enrolment
Anticipated
Actual
12/02/2016
Date of last data collection
Anticipated
Actual
27/04/2016
Sample size
Target
32
Accrual to date
Final
33
Recruitment outside Australia
Country [1] 7326 0
New Zealand
State/province [1] 7326 0
Otago

Funding & Sponsors
Funding source category [1] 292367 0
Commercial sector/Industry
Name [1] 292367 0
Juno Pharmaceuticals Pty Ltd
Country [1] 292367 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
PO Box 1777
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 291053 0
None
Name [1] 291053 0
Address [1] 291053 0
Country [1] 291053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293837 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293837 0
Ethics committee country [1] 293837 0
New Zealand
Date submitted for ethics approval [1] 293837 0
Approval date [1] 293837 0
08/11/2015
Ethics approval number [1] 293837 0
15/CEN/170

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61482 0
Dr Noelyn Hung
Address 61482 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 61482 0
New Zealand
Phone 61482 0
+6434779669
Fax 61482 0
+6434779605
Email 61482 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 61483 0
Linda Folland
Address 61483 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 61483 0
New Zealand
Phone 61483 0
+6434779669
Fax 61483 0
+6434779605
Email 61483 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 61484 0
Cheung-Tak Hung
Address 61484 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 61484 0
New Zealand
Phone 61484 0
+6434779669
Fax 61484 0
+6434779605
Email 61484 0
tak.hung@zenithtechnology.co.nz

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.