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Trial registered on ANZCTR


Registration number
ACTRN12622000141741
Ethics application status
Approved
Date submitted
11/01/2022
Date registered
27/01/2022
Date last updated
16/03/2022
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w trandermal patch against the innovator 32-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w trandermal patch conducted under fasting conditions in healthy male and female volunteers.
Scientific title
A single centre, single application, randomized, open-label, bioequivalence study of a test formulation of 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w trandermal patch in a 2 way crossover comparison against the innovator 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w trandermal patch conducted under fasting conditions in healthy male and female volunteers.
Secondary ID [1] 305543 0
None
Universal Trial Number (UTN)
U1111-1255-2379
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
2-(diethylamino-N-(2,6-dimethylphenyl)acetamide is used as a local anaesthetic. It is indicated for symptomatic relief of nerve pain associated with medically diagnosed post-herpetic neuralgia (post-shingles pain). 323934 0
Condition category
Condition code
Anaesthesiology 321447 321447 0 0
Pain management
Neurological 322407 322407 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 2 x 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w patches on one occasion and the innovator formulation 2 x 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w patches on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test patch formulation

The two transdermal patches will be applied to the lower mid back area and kept in place for 12 hours. In the second study period the patches will be applied on the contralateral side of the body.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing.

Participants are required not to eat for 10 hours before dosing 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 24 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 urine dipstick drugs of abuse testing 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.
Intervention code [1] 321943 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation of 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide (2 x 5% w/w) on one occasion and the innovator formulation of 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide on one occasion with each dose separated by a one week washout period. The comparator/control for this trial is the innovator patch formulation
Control group
Active

Outcomes
Primary outcome [1] 329231 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 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 329231 0
0 (pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 28, and 36 hours post dosing.
Secondary outcome [1] 401839 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] 401839 0
0 (pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 28, and 36 hours post dosing.
Secondary outcome [2] 405107 0
The tolerability of the formulations will be assessed (ie. local irritation, adhesiveness and sensitisation of the test patch in comparison to the reference patch). Observation and evaluation of the skin at the patch site will be performed with reference to the applicable sections of the Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage forms.
Timepoint [2] 405107 0
0 (pre-dose), 12 (immediately following patch removal) and at 14, 24 and 36 hours post-application.
Secondary outcome [3] 405117 0
The safety of the formulations will be measured using vital signs consisting of heart rate & blood pressure (measured by a Digital Sphygmomanometer), respiratory rate (measured manually) and temperature (measured by a Digital Eye Thermometer).
Timepoint [3] 405117 0
0 (pre-dose), 8 and 28 hours after dosing

Eligibility
Key inclusion criteria
Healthy males and females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33 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 any of the medicines or ingredients
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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 30 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)
The subject ID will be used to randomise each participant onto the study. Allocation concealment will be completed by the pharmacy staff who are independent of subject recruitment and who are unaware of the identity of each subject.

All staff obtaining consent and confirming eligibility will remain blinded as to what formulation each subject ID has been allocated. Individual randomisation envelopes will be provided in case the identity of study drug administered to a participant needs to be known.
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 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
14/02/2022
Actual
25/02/2022
Date of last participant enrolment
Anticipated
Actual
25/02/2022
Date of last data collection
Anticipated
Actual
7/03/2022
Sample size
Target
24
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 24204 0
New Zealand
State/province [1] 24204 0
Otago

Funding & Sponsors
Funding source category [1] 309908 0
Commercial sector/Industry
Name [1] 309908 0
Aspen Australia
Country [1] 309908 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
PO Box 1777
156 Frederick St
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 310940 0
None
Name [1] 310940 0
Address [1] 310940 0
Country [1] 310940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309630 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 309630 0
Ethics committee country [1] 309630 0
New Zealand
Date submitted for ethics approval [1] 309630 0
25/11/2020
Approval date [1] 309630 0
18/12/2020
Ethics approval number [1] 309630 0
20/STH/218

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

Contacts
Principal investigator
Name 114834 0
Dr Noelyn Hung
Address 114834 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 114834 0
New Zealand
Phone 114834 0
+64 21 482 148
Fax 114834 0
+64 3 477 9605
Email 114834 0
[email protected]
Contact person for public queries
Name 114835 0
Linda Folland
Address 114835 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 114835 0
New Zealand
Phone 114835 0
+64 3 477 9669
Fax 114835 0
+64 3 477 9605
Email 114835 0
[email protected]
Contact person for scientific queries
Name 114836 0
Tak Hung
Address 114836 0
Zenith Technology Corp Ltd
PO Box 1777
156 Frederick St
Dunedin 9054
Country 114836 0
New Zealand
Phone 114836 0
+64 3 477 9669
Fax 114836 0
+64 3 477 9605
Email 114836 0
[email protected]

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


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.