Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001650482
Ethics application status
Approved
Date submitted
29/11/2016
Date registered
30/11/2016
Date last updated
21/07/2024
Date data sharing statement initially provided
21/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of voriconazole suspension against the innovator voriconazole suspension conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of voriconazole suspension in a 2 way crossover comparison against the innovator voriconazole suspension conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 290642 0
Nil
Universal Trial Number (UTN)
U1111-1188-6136
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers comparing two formulations of voriconazole 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, voriconazole is a triazole antifungal agent that is used to treat fungal and yeast infections. 301164 0
Condition category
Condition code
Infection 300928 300928 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of voriconazole (1 x 200mg/5mL) on one occasion and the innovator formulation of voriconazole (1 x 200mg/5mL) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of voriconazole.

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 and will be monitored 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 health of participants along with HIV, Hepatitis and drugs of abuse testing.

Each dose 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.
Intervention code [1] 296525 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of voriconazole (1 x 200mg/5mL) on one occasion and the innovator formulation of clobazam (1 x 200mg/5mL) on one occasion with each dose seperated by a one week washout period. The comparator/control for this trial is the innovator formulation of voriconazole.
Control group
Active

Outcomes
Primary outcome [1] 300346 0
To compare the bioavailability of voriconazole (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for voriconazole using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 300346 0
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24 and 32 hours post dosing.
Secondary outcome [1] 329757 0
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 329757 0
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24 and 32 hours post dosing.

Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 30 inclusive
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
Sensitivity to voriconazole or any other similar class of medicines, or the excipients of voriconazole
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are 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 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, the Section Head - Trials and Regulatory Affairs. or their delegates. The Trial Physician and Principal Investigator are completely blinded and do not know what treatments are allocated to each subject who has been deemed eligible for participation. Allocation concealment to each formulation is completed by central randomisation by computer.
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. Allocation of the subject number is completed by simple randomisation using a randomisation table created by computer software.
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
1/12/2016
Actual
14/12/2016
Date of last participant enrolment
Anticipated
7/12/2016
Actual
26/01/2017
Date of last data collection
Anticipated
16/12/2016
Actual
3/02/2017
Sample size
Target
24
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 8422 0
New Zealand
State/province [1] 8422 0
Otago

Funding & Sponsors
Funding source category [1] 295077 0
Commercial sector/Industry
Name [1] 295077 0
Generic Partners Pty Ltd
Country [1] 295077 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
North Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 293889 0
None
Name [1] 293889 0
Address [1] 293889 0
Country [1] 293889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296428 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 296428 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 296428 0
New Zealand
Date submitted for ethics approval [1] 296428 0
13/10/2016
Approval date [1] 296428 0
02/11/2016
Ethics approval number [1] 296428 0
16/CEN/160

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 200mg/5mL voriconazole suspension against the reference formulation (innovator brand of 1 x 200mg/5mL voriconazole suspension) following oral administration of a single dose of 1 x 200mg/5mL in healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70822 0
Dr Noelyn Hung
Address 70822 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 70822 0
New Zealand
Phone 70822 0
+6434779669
Fax 70822 0
+6434779605
Email 70822 0
[email protected]
Contact person for public queries
Name 70823 0
Linda Folland
Address 70823 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 70823 0
New Zealand
Phone 70823 0
+6434779669
Fax 70823 0
+6434779605
Email 70823 0
[email protected]
Contact person for scientific queries
Name 70824 0
Cheung-Tak Hung
Address 70824 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 70824 0
New Zealand
Phone 70824 0
+6434779669
Fax 70824 0
+6434779605
Email 70824 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.

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