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Trial registered on ANZCTR
Registration number
ACTRN12613001131741
Ethics application status
Approved
Date submitted
8/10/2013
Date registered
10/10/2013
Date last updated
13/10/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of quetiapine prolonged release tablet against the innovator quetiapine tablet conducted under fasting conditions in healthy male and female volunteers
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Scientific title
A single dose, randomized, blinded, bioequivalence study of quetiapine prolonged release tablets in a 2 way crossover comparison against the innovator quetiapine tablet conducted under fasting conditions in healthy male and female volunteers
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Secondary ID [1]
283376
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None
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Universal Trial Number (UTN)
U1111-1148-4773
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers comparing two formulations of quetiapine 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, quetiapine belongs to a class of medicines called an atypical antipsychotic drug and is prescribed for the maintenance treatment of Bipolar and schizophrenia.
290277
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Condition category
Condition code
Other
290663
290663
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single dose, crossover over study design whereby each participant receives the test formulation of quetiapine (1 x 200 mg prolonged release) on one occasion and the innovator formulation of quetiapine (1 x 200 mg prolonged release) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of quetiapine.
Each dose (1 x 200 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 10 hours before receiving each dose and to fast for 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 10 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 with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing.
Pre and post study laboratory tests will be completed to assess the healthy of participants along with HIV, Hepatitis and drugs of abuse testing.
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Intervention code [1]
288099
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Treatment: Drugs
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Comparator / control treatment
Single dose, crossover over study design whereby each participant receives the test formulation of quetiapine (1 x 200 mg prolonged release) on one occasion and the innovator formulation of quetipine (1 x 200 mg prolonged release) on one occasion with each dose seperated by a one week washout period. The comparator/control for this trial is the innovator formulation of quetiapine.
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Control group
Active
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Outcomes
Primary outcome [1]
290676
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To compare the bioavailability of quetiapine (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for quetiapine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
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Assessment method [1]
290676
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Timepoint [1]
290676
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0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0 and 48.0 hours
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Secondary outcome [1]
305017
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Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant.
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Assessment method [1]
305017
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Timepoint [1]
305017
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0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0 and 48.0 hours
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Eligibility
Key inclusion criteria
Healthy males and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 19 and 30
Normal, healthy individuals as determined by medical history, physical examination, ECG, bood pressure and laboratory tests
Able to provide written informed consent
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives
Who have receievd an investigational compound or drug known to induce or inhibit liver enqymes within 60 days of the start of the study
Who have a history of abnormal heartbeats or frequent palpitations or who have a family history of long QTc syndrome
History or family history of depression or other mental illness, epilepsy or seizures
Sensitivity to quetiapine, any antipsychotic medicines, excipients of quetiapine
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Who are lactose intolerant
Females who are breastfeeding or are planning to start a family within 60 days of dosing
Who are planning on having any surgical or dental procedures within 4 weeks of the study completion
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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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.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Bio-equivalence
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
28/10/2013
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Actual
18/11/2013
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Date of last participant enrolment
Anticipated
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Actual
4/12/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5489
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New Zealand
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State/province [1]
5489
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Otago
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Funding & Sponsors
Funding source category [1]
288099
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Commercial sector/Industry
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Name [1]
288099
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Actavis Group PTC ehf
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Address [1]
288099
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Reykjavikurvegur 76-78
220 Hafnarfjordur
ICELAND
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Country [1]
288099
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Iceland
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Primary sponsor type
Commercial sector/Industry
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Name
Zenith Technology Corporation Limited
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Address
156 Frederick Street
Dunedin 9016
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Country
New Zealand
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Secondary sponsor category [1]
286819
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None
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Name [1]
286819
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Address [1]
286819
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Country [1]
286819
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290022
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Southern Health & Disability Ethics Committee
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Ethics committee address [1]
290022
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Ministry of Health 1 the Terrace PO Box 5013 Wellington 6145
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Ethics committee country [1]
290022
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New Zealand
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Date submitted for ethics approval [1]
290022
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04/10/2013
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Approval date [1]
290022
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22/10/2013
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Ethics approval number [1]
290022
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13/STH/127
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Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 200 mg quetiapine prolonged release tablet relative to that of the reference formulation (innovator brand of 200 mg quetiapine prolonged release tablet) following oral administration of a single dose of 200 mg in healthy male and female subjects under fasting conditions.
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Trial website
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Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
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Public notes
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Contacts
Principal investigator
Name
43554
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Dr Noelyn Hung
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Address
43554
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Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
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Country
43554
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New Zealand
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Phone
43554
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+6434779669
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Fax
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Email
43554
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[email protected]
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Contact person for public queries
Name
43555
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Linda Folland
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Address
43555
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Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
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Country
43555
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New Zealand
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Phone
43555
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+6434779669
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Fax
43555
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Email
43555
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[email protected]
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Contact person for scientific queries
Name
43556
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Cheung- Tak Hung
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Address
43556
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Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
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Country
43556
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New Zealand
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Phone
43556
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+6434779669
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Fax
43556
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Email
43556
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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