Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001446853
Ethics application status
Approved
Date submitted
30/09/2021
Date registered
25/10/2021
Date last updated
7/09/2022
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of a combination N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension against two innovator formulations administered simultaneously of N-(4-hydroxyphenyl)acetamide oral suspension and (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.
Scientific title
A single dose, randomized, open label bioequivalence study of a generic formulation of 10ml of a combination 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension in a 2 way crossover comparison against two innovator formulations administered simultaneously of 5 ml of 250 mg of N-(4-hydroxyphenyl)acetamide oral suspension and 5 ml of 100 mg of (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.
Secondary ID [1] 305051 0
None
Universal Trial Number (UTN)
U1111-1268-3443
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N-(4-hydroxyphenyl)acetamide is an effective analgesic and antipyretic. It is indicated for the temporary relief of pain, discomfort associated with teething, headache, earache, immunisation, toothache, cold and flu, and it reduces fever.

 323508 0
(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid is a nonsteroidal anti-inflammatory drug used for the temporary relief of fever, pain associated with teething, toothache, earache, sore throat, headache, minor ache, sprain, strain, cold and flu. 324013 0
Condition category
Condition code
Anaesthesiology 321069 321069 0 0
Pain management
Inflammatory and Immune System 321518 321518 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The combination test formulation of 1 x 10 ml of 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension on one occasion. The intervention for this trial is the test oral suspension 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 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 14 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. The standard meals will be consumed 4 hours and 9 hours after dosing (at approximately 12pm and 5pm). 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 swallow the entire suspension and a mouth check will be conducted to ensure that the medication has been taken as directed.
Intervention code [1] 321626 0
Treatment: Drugs
Comparator / control treatment
The two innovator formulations administered simultaneously of 1 x 5 ml of 250 mg of N-(4-hydroxyphenyl)acetamide oral suspension and 1 x 5 ml of 100 mg of (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension on one occasion. The comparator/control for this trial is the innovator formulation.
Control group
Active

Outcomes
Primary outcome [1] 328845 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 N-(4-hydroxyphenyl)acetamide and (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 328845 0
0 (pre-dose) and at 10 min, 20 min, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 14 hours post dosing.
Secondary outcome [1] 400627 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] 400627 0
0 (pre-dose) and at 10 min, 20 min, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 14 hours post 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)
All formulations will be labeled as Formulation A and B. Treatments will be allocated randomly. The identification of each treatment will only be known to the Managing Director and the Section head - Trials and Regulatory Affairs.
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 subject number (randomisation number) after acceptance into the study. 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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The sponsor company decided to abandon the project based on several commercial and regulatory risks.
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 24100 0
New Zealand
State/province [1] 24100 0
Otago

Funding & Sponsors
Funding source category [1] 309447 0
Commercial sector/Industry
Name [1] 309447 0
Aspen Pharmacare Australia
Country [1] 309447 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 310414 0
None
Name [1] 310414 0
Address [1] 310414 0
Country [1] 310414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309240 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309240 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 309240 0
New Zealand
Date submitted for ethics approval [1] 309240 0
29/06/2021
Approval date [1] 309240 0
20/07/2021
Ethics approval number [1] 309240 0
21/NTB/162

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to that of the reference formulations, following oral administration of a single 10 ml dose of 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid to healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113458 0
Dr Noelyn Hung
Address 113458 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 113458 0
New Zealand
Phone 113458 0
+64 21 482 148
Fax 113458 0
+64 3 477 9605
Email 113458 0
[email protected]
Contact person for public queries
Name 113459 0
Mrs Linda Folland
Address 113459 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 113459 0
New Zealand
Phone 113459 0
+64 3 477 9669
Fax 113459 0
+64 3 477 9605
Email 113459 0
[email protected]
Contact person for scientific queries
Name 113460 0
Dr Tak Hung
Address 113460 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 113460 0
New Zealand
Phone 113460 0
+64 3 477 9669
Fax 113460 0
+64 3 477 9605
Email 113460 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. 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 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.