Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000776303
Ethics application status
Approved
Date submitted
26/05/2017
Date registered
29/05/2017
Date last updated
13/10/2021
Date data sharing statement initially provided
13/10/2021
Date results information initially provided
13/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of dofetilide capsule against the innovator dofetilide capsule conducted under fasting condition in healthy male and female volunteers.
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of dofetilide capsule in a 2 way crossover comparison against the innovator dofetilide capsule conducted under fasting conditions in healthy male and female volunteers.
Secondary ID [1] 292059 0
Nil
Universal Trial Number (UTN)
U1111-1196-2353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 303467 0
Condition category
Condition code
Cardiovascular 302874 302874 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 0.5 mg dofetilide capsule on one occasion and the innovator formulation of 0.5 mg dofetilide capsule on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test tablet formulation.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for 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 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 ( 1 x. 0.5 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.
Intervention code [1] 298192 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation (1 x 0.5 mg) on one occasion and the innovator formulation of dofetilide (1 x 0.5 mg) on one occasion with each dose separated by a one week washout period. The comparator/control for this trial is the innovator capsule formulation.
Control group
Active

Outcomes
Primary outcome [1] 302264 0
To compare the bioavailability of dofetilide (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for dofetilide using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 302264 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12, 14, 18, 24, 32 and 48 hours post dosing.
Secondary outcome [1] 335316 0
The 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] 335316 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12, 14, 18, 24, 32 and 48 hours post dosing.

Eligibility
Key inclusion criteria
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 19 and 30
Normal QTc for males and females
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
Any history of congenital or acquired long QT syndrome
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or 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 within the 60 days preceding the study
Volunteers for whom the Clinical Investigator believer, 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 - Trails and Regulatory Affairs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be given 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. Sequence generation will be by using a 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
Completed
Date of first participant enrolment
Anticipated
31/05/2017
Actual
9/06/2017
Date of last participant enrolment
Anticipated
Actual
11/06/2017
Date of last data collection
Anticipated
Actual
28/06/2017
Sample size
Target
24
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 8923 0
New Zealand
State/province [1] 8923 0
Otago

Funding & Sponsors
Funding source category [1] 296592 0
Commercial sector/Industry
Name [1] 296592 0
Douglas Pharmaceuticals America Ltd
Country [1] 296592 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 295544 0
None
Name [1] 295544 0
Address [1] 295544 0
Country [1] 295544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297813 0
Northern A Health and Disability Ethics COmmittee
Ethics committee address [1] 297813 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 297813 0
New Zealand
Date submitted for ethics approval [1] 297813 0
04/05/2017
Approval date [1] 297813 0
16/05/2017
Ethics approval number [1] 297813 0
17/NTA/85

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 single dose of 0.5 mg dofetilide capsule to healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75178 0
Dr Noelyn Hung
Address 75178 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 75178 0
New Zealand
Phone 75178 0
+6434779669
Fax 75178 0
Email 75178 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 75179 0
Mrs Linda Folland
Address 75179 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 75179 0
New Zealand
Phone 75179 0
+6434779669
Fax 75179 0
Email 75179 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 75180 0
Dr Cheung-Tak Hung
Address 75180 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 75180 0
New Zealand
Phone 75180 0
+6434779669
Fax 75180 0
Email 75180 0
tak.hung@zenithtechnology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.