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Trial registered on ANZCTR


Registration number
ACTRN12620000346976
Ethics application status
Approved
Date submitted
9/03/2020
Date registered
11/03/2020
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet against the innovator 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet conducted under fed conditions in healthy volunteers.
Scientific title
A single dose, randomized, open-label, pharmacokinetic study of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet in a 2 way crossover comparison against the innovator 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet conducted under fed conditions in healthy volunteers.
Secondary ID [1] 300722 0
None
Universal Trial Number (UTN)
U1111-1235-0807
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone belongs to a class of medicines called opioid analgesics and is prescribed for the relief of severe pain. 316541 0
Condition category
Condition code
Anaesthesiology 314784 314784 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of
1 x 5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet on one occasion and the innovator formulation of 1 x 5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test tablet formulation.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose).


Participants are required not to eat for 10 hours before receiving a standardised high fat content meal and to fast for approximately 4 hours after each dose.

Bathroom visits will be supervised to ensure no unauthorized 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 for 26 hours after dosing.

Participants will be monitored for adverse events throughout the study.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and dipstick drugs of abuse tests will be performed upon each participant reporting to the clinical site 12 hours prior to dosing.

Screening and study exit laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing.

Each dose 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 that the medication has been taken as directed.
Intervention code [1] 317043 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation 1 x 5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet on one occasion and the innovator formulation of 1 x 5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet on one occasion with each dose separated by a one week washout period. The comparator/control for this trial is the innovator formulation.
Control group
Active

Outcomes
Primary outcome [1] 323141 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one s using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 323141 0
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 14, 18, 26 and 36 hours post dosing.
Secondary outcome [1] 380947 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] 380947 0
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 14, 18, 26 and 36 hours post dosing

Eligibility
Key inclusion criteria
Healthy males and non-pregnant females
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18.5 and less than 32 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant medical conditions
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Participation in a drug study within 30 days of the start of the study
Sensitivitie to the study drug or excipients
Individuals 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 labeled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and Section Head - Trials and Regulatory Affairs or their delegate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 study number (randomisation number) after acceptance into the study. Randomization will be performed using a randomisation table created by computer software (i.e. computerized sequence generation).
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
Not yet recruiting
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] 22422 0
New Zealand
State/province [1] 22422 0
Otago

Funding & Sponsors
Funding source category [1] 305169 0
Commercial sector/Industry
Name [1] 305169 0
AU Pharma Pty Ltd
Address [1] 305169 0
Unit 3, 57 Avalon Parade
Avalon Beach 2107
Country [1] 305169 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
PO Box 1777
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 305530 0
None
Name [1] 305530 0
Address [1] 305530 0
Country [1] 305530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305533 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305533 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6145
Ethics committee country [1] 305533 0
New Zealand
Date submitted for ethics approval [1] 305533 0
25/06/2019
Approval date [1] 305533 0
08/08/2019
Ethics approval number [1] 305533 0
19/STH/125

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation
5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride tablet
relative to that of the reference formulation following oral administration of a single dose of 5/2.5 mg 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride tablet in healthy subjects under fed conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100698 0
Dr Noelyn Hung
Address 100698 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 100698 0
New Zealand
Phone 100698 0
+64 3 477 9669
Fax 100698 0
+6434779605
Email 100698 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 100699 0
Mrs Linda Folland
Address 100699 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 100699 0
New Zealand
Phone 100699 0
+64 3 477 9669
Fax 100699 0
+6434779605
Email 100699 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 100700 0
Dr Tak Hung
Address 100700 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 100700 0
New Zealand
Phone 100700 0
+64 3 477 9669
Fax 100700 0
+6434779605
Email 100700 0
tak.hung@zenithtechnology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported
What supporting documents are/will be available?
No other documents available
Summary results
No Results