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Trial registered on ANZCTR


Registration number
ACTRN12615000280505
Ethics application status
Approved
Date submitted
19/03/2015
Date registered
25/03/2015
Date last updated
30/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of clonidine tablet against the innovator clonidine tablet conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of clonidine tablet in a 2 way crossover comparison against the innovator clonidine tablet conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 286380 0
None
Universal Trial Number (UTN)
U-1111-1167-8398
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers comparing two formulations of clonidine 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, clonidine is an antihypertensive (central alpha2-agonist). It is indicated for the treatment of all grades of essential hypertension including renal, migraine, recurrent vascular headache prophylaxis and menopausal flushing.
294523 0
Condition category
Condition code
Other 294829 294829 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
Single dose, crossover study design whereby each participant receives the test formulation of clonidine (1 x 100 mcg) on one occasion and the innovator formulation of clonidine (1 x 100 mcg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of clonidine.

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 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 12 hours prior to dosing to ensure compliance and will 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 12 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 100 mcg) 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] 291445 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of clonidine (1 x 100 mcg) on one occasion and the innovator formulation of clonidine (1 x 100 mcg) on one occasion with each dose seperated by a one week washout period. The comparator/control for this trial is the innovator formulation of clonidine.
Control group
Active

Outcomes
Primary outcome [1] 294594 0
To compare the bioavailability of clonidine (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for clonidine using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 294594 0
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 18, 24, 32, 48 and 56 hours
Secondary outcome [1] 313688 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] 313688 0
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 18, 24, 32, 48 and 56 hours

Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33 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
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
Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
Sensitivity to clonidine or any other similar class of medicines, or the excipients of clonidine
Who are galactose intolerance eg galactosaemia
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
Who are planning to start a family within 60 days of receiving the final dose.
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 generation).
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
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] 6758 0
New Zealand
State/province [1] 6758 0
Otago

Funding & Sponsors
Funding source category [1] 290953 0
Commercial sector/Industry
Name [1] 290953 0
Southern Cross Pharma Pty Ltd
Address [1] 290953 0
56 Illabunda Drive
Malua Bay
NSW 2536
Country [1] 290953 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 289635 0
None
Name [1] 289635 0
Address [1] 289635 0
Country [1] 289635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292551 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292551 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 292551 0
New Zealand
Date submitted for ethics approval [1] 292551 0
04/03/2015
Approval date [1] 292551 0
18/03/2015
Ethics approval number [1] 292551 0
15/STH/33

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 100 mcg clonidine tablet against the reference formulation (innovator brand of 1 x 100 mcg clonidine tablet) following oral administration of a single dose of 1 x 100 mcg in healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55894 0
Dr Noelyn Hung
Address 55894 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 55894 0
New Zealand
Phone 55894 0
+6434779669
Fax 55894 0
+6434779605
Email 55894 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 55895 0
Mrs Linda Folland
Address 55895 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 55895 0
New Zealand
Phone 55895 0
+6434779669
Fax 55895 0
+6434779605
Email 55895 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 55896 0
Dr Cheung-Tak Hung
Address 55896 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 55896 0
New Zealand
Phone 55896 0
+6434779669
Fax 55896 0
+6434779605
Email 55896 0
tak.hung@zenithtechnology.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary