Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001321336
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
14/09/2017
Date last updated
14/07/2024
Date data sharing statement initially provided
14/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of alpha,alpha-dimethylphenethylamine tablet against the innovator alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions and at steady state in healthy male and female volunteers.
Scientific title
A multiple dose, randomized, blinded, bioequivalence study of a test formulation of alpha,alpha-dimethylphenethylamine tablet in a 2 way crossover comparison against the innovator alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions and at steady state in healthy male and female volunteers.
Secondary ID [1] 292858 0
None
Universal Trial Number (UTN)
U1111-1192-6812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alpha,alpha-dimethylphenethylamine is a C5 Controlled Drug indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regime of weight reduction. 304698 0
Condition category
Condition code
Diet and Nutrition 304009 304009 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mutliple dose, crossover study design whereby each participant receives the test formulation of alpha,alpha-dimethylphenethylamine oral tablet (1 x 40 mg) on five occasions and the innovator formulation of alpha,alpha-dimethylphenethylamine oral capsule (1 x 40 mg) on five occasions with each dose separated by a 10 day washout period. The intervention for this trial is the test tablet formulation.

On study days 1-5 subjects will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test).

Each dose (1 x 40 mg) 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.

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 4 hours before receiving each dose on study days 1 to 4 and 15 to 18.

On study days 1 and 15 subjects will report to the Zenith Clinical Site for dosing and observation of adverse events and the provision of one blood sample. They are required to stay at the clinical site for 24 hours after dosing.

On study days 2 to 4 and 16 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample.

On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and subjects are required to fast for 8 hours prior to receiving the dose and 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 8 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing.

Standard meals will be consumed at the Clinical Site on study days 5 and 19 with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 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.
Intervention code [1] 299099 0
Treatment: Drugs
Comparator / control treatment
Multiple dose, crossover study design whereby each participant receives the test formulation of alpha,alpha-dimethylphenethylamine tablet (1 x 40 mg) on five occasions and the innovator formulation of alpha,alpha-dimethylphenethylamine capsule (1 x 40 mg) on five occasions with each dose separated by a 10 day washout period. The comparator/control for this trial is the innovator capsule formulation.
Control group
Active

Outcomes
Primary outcome [1] 303342 0
To compare the bioavailability of alpha,alpha-dimethylphenethylamine (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for alpha,alpha-dimethylphenethylamine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 303342 0
Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20 and 24 hours post dosing.
Secondary outcome [1] 338707 0
Time to maximum peak concentration (Tmax). Tmax will be the time where the maximum concentration occurred in the sample points. All plasma samples will be assayed for alpha,alpha-dimethylphenethylamine using a fully validated LC/MS/MS method.
Timepoint [1] 338707 0
Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20 and 24 hours post dosing.

Eligibility
Key inclusion criteria
Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 30
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
History of psychiatric illness including anorexia nervosa and depression
Females who are pregnant or breast-feeding
Sensitivity to the study drug or its 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 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. Sequence generation will be by using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
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
Completed
Date of first participant enrolment
Anticipated
18/09/2017
Actual
26/09/2017
Date of last participant enrolment
Anticipated
Actual
31/10/2017
Date of last data collection
Anticipated
Actual
19/11/2017
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 9196 0
New Zealand
State/province [1] 9196 0
Otago

Funding & Sponsors
Funding source category [1] 297489 0
Commercial sector/Industry
Name [1] 297489 0
Juno PC Holdings Pty Ltd
Country [1] 297489 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 296495 0
None
Name [1] 296495 0
Address [1] 296495 0
Country [1] 296495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298590 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 298590 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 298590 0
New Zealand
Date submitted for ethics approval [1] 298590 0
09/02/2017
Approval date [1] 298590 0
02/03/2017
Ethics approval number [1] 298590 0
17/NTA/22

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) tablet formulation relative to that of the capsule reference formulation following oral administration of a multiple dose of 40 mg alpha,alpha-dimethylphenethylamine to healthy male and female subjects under fasting conditions and at steady state.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77582 0
Dr Noelyn Hung
Address 77582 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 77582 0
New Zealand
Phone 77582 0
+6434779669
Fax 77582 0
+6434779605
Email 77582 0
[email protected]
Contact person for public queries
Name 77583 0
Linda Folland
Address 77583 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 77583 0
New Zealand
Phone 77583 0
+6434779669
Fax 77583 0
+6434779605
Email 77583 0
[email protected]
Contact person for scientific queries
Name 77584 0
Tak Hung
Address 77584 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 77584 0
New Zealand
Phone 77584 0
+6434779669
Fax 77584 0
+6434779605
Email 77584 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

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