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Trial registered on ANZCTR


Registration number
ACTRN12617001219370
Ethics application status
Approved
Date submitted
17/08/2017
Date registered
21/08/2017
Date last updated
21/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 40 mg/mL posaconazole oral suspension against the innovator posaconazole oral suspension conducted under fed conditions in healthy male & female volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of posaconazole oral suspension in a 3 way crossover comparison against the innovator posaconazole oral suspension conducted under fed conditions in healthy male & female volunteers
Secondary ID [1] 292655 0
None
Universal Trial Number (UTN)
U1111-1199-1882
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fungal infections 304390 0
Condition category
Condition code
Infection 303723 303723 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 posaconazole (1 x 40 mg/mL) oral suspension on one occasion and the innovator formulation of posaconazole (1 x 40 mg/mL) oral suspension on two occasions with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of posaconazole.

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 prior to receiving breakfast. Subjects will be provided with a standardised high fat breakfast which they must start eating 30 minutes prior to dosing. Subjects are required 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.

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 administered orally through a syringe and swallowed with 240 ml of water at ambient temperature. The full amount of suspension must be swallowed and a mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 298891 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of posaconazole (1 x 40 mg/mL) oral suspension on one occasion and the innovator formulation of posaconazole (1 x 40 mg/mL) oral suspension on two occasions with each dose seperated by a one week washout period. The comparator/control for this trial is the innovator formulation of posaconazole.
Control group
Active

Outcomes
Primary outcome [1] 303096 0
To compare the bioavailability of posaconazole (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for posaconazole using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU guidelines.
Timepoint [1] 303096 0
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 18, 24, 32, 48, 56 and 72 hours post dosing
Secondary outcome [1] 337871 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] 337871 0
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 18, 24, 32, 48, 56 and 72 hours post dosing

Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 55 inclusive
Non-smoker
BMI between 18.5 and 30.0 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, vital signs 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
Sensitivity to posaconazole or any other similar class of medicines, or the excipients of posaconazole
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of cardiac problems or conditions
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, B and C. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.
The method of allocation concealment will be determined 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.
The method of sequence generation will be completed by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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] 9147 0
New Zealand
State/province [1] 9147 0
Otago

Funding & Sponsors
Funding source category [1] 297289 0
Commercial sector/Industry
Name [1] 297289 0
Douglas Pharmaceuticals Ltd
Address [1] 297289 0
Central Park Drive
PO Box 45-027
Auckland 0610
Country [1] 297289 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 296258 0
None
Name [1] 296258 0
Address [1] 296258 0
Country [1] 296258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298399 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 298399 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 298399 0
New Zealand
Date submitted for ethics approval [1] 298399 0
12/07/2017
Approval date [1] 298399 0
01/08/2017
Ethics approval number [1] 298399 0
17/CEN/134

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 40 mg/mL posaconazole oral suspension against the reference formulation (innovator brand of 1 x 40 mg/mL posaconazole oral suspension) following oral administration of a single dose of 40mg/mL in healthy male and female subjects under fed conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76958 0
Dr Noelyn Hung
Address 76958 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 76958 0
New Zealand
Phone 76958 0
+6434779669
Fax 76958 0
+6434779605
Email 76958 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 76959 0
Mrs Linda Folland
Address 76959 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 76959 0
New Zealand
Phone 76959 0
+6434779669
Fax 76959 0
+6434779605
Email 76959 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 76960 0
Dr Tak Hung
Address 76960 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 76960 0
New Zealand
Phone 76960 0
+6434779669
Fax 76960 0
+6434779605
Email 76960 0
tak.hung@zenithtechnology.co.nz

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