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Trial registered on ANZCTR


Registration number
ACTRN12617001132336
Ethics application status
Approved
Date submitted
31/07/2017
Date registered
2/08/2017
Date last updated
2/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule against the innovator 2-methyl-1-phenylpropan-2-amine (122-09-8) 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 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule in a 2 way crossover comparison against the innovator 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule conducted under fasting conditions and at steady state in healthy male and female volunteers.
Secondary ID [1] 292560 0
Nil
Universal Trial Number (UTN)
U1111-1197-1741
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
2-methyl-1-phenylpropan-2-amine (122-09-8) 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. 304227 0
Condition category
Condition code
Diet and Nutrition 303577 303577 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 40 mg 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule on five occasions and the innovator formulation of 40 mg 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule on five occasions with each dose separated by a 10 day washout period. The intervention for this trial is the test capsule 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 10 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] 298765 0
Treatment: Drugs
Comparator / control treatment
Multiple dose, crossover study design whereby each participant receives the test formulation of 2-methyl-1-phenylpropan-2-amine (122-09-8) (1 x 40 mg) on five occasions and the innovator formulation of 2-methyl-1-phenylpropan-2-amine (122-09-8) (1 x 40 mg) on five occasions with each dose seperated by a 10 day washout period. The comparator/control for this trial is the innovator formulation of 2-methyl-1-phenylpropan-2-amine (122-09-8). Both formulations will be given as an oral capsule.
Control group
Active

Outcomes
Primary outcome [1] 302933 0
To compare the bioavailability of 2-methyl-1-phenylpropan-2-amine (122-09-8) (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for 2-methyl-1-phenylpropan-2-amine (122-09-8) using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 302933 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 after dosing on study days 5 and 19.
Secondary outcome [1] 337479 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 2-methyl-1-phenylpropan-2-amine (122-09-8) using a fully validated LC/MS/MS method.
Timepoint [1] 337479 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 after dosing on study days 5 and 19.

Eligibility
Key inclusion criteria
Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33
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
Gender
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 (excluding prescribed hormonal contraceptives
History of depression, anxiety, obsessive-compulsive disorder, or post-traumatic stress syndrome
Pregnant or breast-feeding
Sensitivity to 2-methyl-1-phenylpropan-2-amine (122-09-8), any antidepressant agents, excipients of 2-methyl-1-phenylpropan-2-amine (122-09-8)
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. Randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generator).
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
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] 9114 0
New Zealand
State/province [1] 9114 0
Otago

Funding & Sponsors
Funding source category [1] 297139 0
Commercial sector/Industry
Name [1] 297139 0
Aspen Australia
Address [1] 297139 0
34-36 Chandos St
St Leonards
NSW 2065
Country [1] 297139 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] 296149 0
None
Name [1] 296149 0
Address [1] 296149 0
Country [1] 296149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298307 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 298307 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 298307 0
New Zealand
Date submitted for ethics approval [1] 298307 0
16/06/2017
Approval date [1] 298307 0
11/07/2017
Ethics approval number [1] 298307 0
17/CEN/112

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to the that of a reference formulation, following oral administration of a combination multiple dose of 40 mg 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule 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 76666 0
Dr Noelyn Hung
Address 76666 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 76666 0
New Zealand
Phone 76666 0
+6434779669
Fax 76666 0
+6434779669
Email 76666 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 76667 0
Mrs Linda Folland
Address 76667 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 76667 0
New Zealand
Phone 76667 0
+6434779669
Fax 76667 0
+6434779605
Email 76667 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 76668 0
Dr Tak Hung
Address 76668 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 76668 0
New Zealand
Phone 76668 0
+6434779669
Fax 76668 0
+6434779605
Email 76668 0
tak.hung@zenithtechnology.co.nz

No data has been provided for results reporting
Summary results
Not applicable