Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000869572
Ethics application status
Approved
Date submitted
6/08/2015
Date registered
21/08/2015
Date last updated
10/05/2019
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 100 mg desvenlafaxine extended release tablet against the innovator 100 mg desvenlafaxine extended release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers
Scientific title
A multiple dose, randomized, blinded, bioequivalence study of 100 mg desvenlafaxine extended release tablets in a 2 way crossover comparison against the innovator 100 mg desvenlafaxine extended release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers
Secondary ID [1] 287210 0
None
Universal Trial Number (UTN)
U1111-1164-8335
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers comparing two formulations of desvenlafaxine with no health condition or problem studied.

Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, desvenlafaxine belongs to a class of medicines called Serotonin-Nonadrenaline Reuptake Inhibitors and is an antidepressant prescribed for the treatment and prevention of relapse of depression. 295804 0
Condition category
Condition code
Other 296067 296067 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple dose, crossover study design whereby each participant receives the test formulation of desvenlafaxine (1 x 100 mg) on five occasions and the innovator formulation of desvenlafaxine (1 x 100 mg) on five occasions with each dose seperated by a 10 day washout period. The intervention for this trial is the test formulation of desvenlafaxine.

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 100 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] 292494 0
Treatment: Drugs
Comparator / control treatment
Multiple dose, crossover study design whereby each participant receives the test formulation of desvenlafaxine (1 x 100 mg) on five occasions and the innovator formulation of desvenlafaxine (1 x 100 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 desvenlafaxine.
Control group
Active

Outcomes
Primary outcome [1] 295741 0
To compare the bioavailability of desvenlafaxine (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for desvenlafaxine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 295741 0
Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 20 and 24 hours after dosing on study days 5 and 19.
Secondary outcome [1] 316384 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 desvenlafaxine using a fully validated LC/MS/MS method.
Timepoint [1] 316384 0
Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 20 and 24 hours after dosing on study days 5 and 19.
Secondary outcome [2] 316717 0
The elimination half life (t1/2). T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. All plasma samples will be assayed for desvenlafaxine using a fully validated LC/MS/MS method.
Timepoint [2] 316717 0
Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 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
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 (excluding prescribed hormonal contraceptives
History of depression, anxiety, obsessive-compulsive disorder, or post-traumatic stress syndrome
Pregnant or breast-feeding
Sensitivity to desvenlafaxine, any antidepressant agents, excipients of desvenlafaxine
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
Completed
Date of first participant enrolment
Anticipated
10/10/2016
Actual
22/11/2016
Date of last participant enrolment
Anticipated
Actual
1/12/2016
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
24
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 7076 0
New Zealand
State/province [1] 7076 0
Otago

Funding & Sponsors
Funding source category [1] 291781 0
Commercial sector/Industry
Name [1] 291781 0
Generic Partners Pty Ltd
Country [1] 291781 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
PO Box 1777
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 290448 0
None
Name [1] 290448 0
Address [1] 290448 0
Country [1] 290448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293300 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 293300 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 293300 0
New Zealand
Date submitted for ethics approval [1] 293300 0
Approval date [1] 293300 0
29/07/2015
Ethics approval number [1] 293300 0
15/STH/111

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 100 mg desvenlafaxine extended release tablet relative to that of the reference formulation (innovator brand of 100 mg desvenlafaxine extended release tablet) following oral administration of a multiple dose of 100 mg in healthy male and female subjects under fasting conditions and at steady state.
Trial website
Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
Public notes

Contacts
Principal investigator
Name 59302 0
Dr Noelyn Hung
Address 59302 0
Zenith Technology Corp Ltd PO Box 1777 Dunedin 9016
Country 59302 0
New Zealand
Phone 59302 0
+6434779669
Fax 59302 0
+6434779605
Email 59302 0
[email protected]
Contact person for public queries
Name 59303 0
Linda Folland
Address 59303 0
Zenith Technology Corp Ltd PO Box 1777 Dunedin 9016
Country 59303 0
New Zealand
Phone 59303 0
+6434779669
Fax 59303 0
+6434779605
Email 59303 0
[email protected]
Contact person for scientific queries
Name 59304 0
Cheung Tak Hung
Address 59304 0
Zenith Technology Corp Ltd PO Box 1777 Dunedin 9016
Country 59304 0
New Zealand
Phone 59304 0
+6434779669
Fax 59304 0
+6434779605
Email 59304 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.