Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000563268
Ethics application status
Approved
Date submitted
12/04/2018
Date registered
13/04/2018
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 1,1-Dimethyl-2-Phenylethylamine 40 mg capsule against the innovator 1,1-Dimethyl-2-Phenylethylamine 40 mg capsule conducted under fasting condition and at steady state in healthy male and female volunteers.
Scientific title
A multiple dose, randomized, blinded, bioequivalence study of a test formulation of 1,1-Dimethyl-2-Phenylethylamine 40 mg capsule in a 2 way crossover comparison against the innovator 1,1-Dimethyl-2-Phenylethylamine 40 mg capsule conducted under fasting and steady state conditions in healthy male and female volunteers.
Secondary ID [1] 294486 0
None
Universal Trial Number (UTN)
U1111-1193-0998
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1,1-Dimethyl-2-Phenylethylamine 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 307254 0
Condition category
Condition code
Diet and Nutrition 306372 306372 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 1,1-Dimethyl-2-Phenylethylamine oral tablet (1 x 40 mg) on five occasions and the innovator formulation of 1,1-Dimethyl-2-Phenylethylamine 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] 300781 0
Treatment: Drugs
Comparator / control treatment
Multiple dose, crossover study design whereby each participant receives the test formulation of 1,1-Dimethyl-2-Phenylethylamine tablet (1 x 40 mg) on five occasions and the innovator formulation of 1,1-Dimethyl-2-Phenylethylamine 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] 305380 0
To compare the bioavailability of 1,1-Dimethyl-2-Phenylethylamine (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for 1,1-Dimethyl-2-Phenylethylamine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 305380 0
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] 345018 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 1,1-Dimethyl-2-Phenylethylamine using a fully validated LC/MS/MS method.
Timepoint [1] 345018 0
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 non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 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
Any history of congenital or acquired long QT syndrome
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or 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 within the 60 days preceding the study
Volunteers for whom the Clinical Investigator believer, 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 - Trails 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
Actual
10/04/2018
Date of last participant enrolment
Anticipated
17/04/2018
Actual
13/04/2018
Date of last data collection
Anticipated
18/04/2018
Actual
7/05/2018
Sample size
Target
24
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 10252 0
New Zealand
State/province [1] 10252 0
Otago

Funding & Sponsors
Funding source category [1] 299112 0
Commercial sector/Industry
Name [1] 299112 0
Generic Partners Pty Ltd
Country [1] 299112 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 298369 0
None
Name [1] 298369 0
Address [1] 298369 0
Country [1] 298369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300044 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 300044 0
Ethics committee country [1] 300044 0
New Zealand
Date submitted for ethics approval [1] 300044 0
15/02/2017
Approval date [1] 300044 0
13/04/2017
Ethics approval number [1] 300044 0
17/CEN/43

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

Contacts
Principal investigator
Name 82374 0
Dr Noelyn Hung
Address 82374 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 82374 0
New Zealand
Phone 82374 0
+6434779669
Fax 82374 0
+6434779605
Email 82374 0
[email protected]
Contact person for public queries
Name 82375 0
Linda Folland
Address 82375 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 82375 0
New Zealand
Phone 82375 0
+6434779669
Fax 82375 0
+6434779605
Email 82375 0
[email protected]
Contact person for scientific queries
Name 82376 0
Tak Hung
Address 82376 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 82376 0
New Zealand
Phone 82376 0
+6434779669
Fax 82376 0
+6434779605
Email 82376 0
[email protected]

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

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