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Trial registered on ANZCTR


Registration number
ACTRN12615001005549
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
28/09/2015
Date last updated
10/05/2019
Date data sharing statement initially provided
10/05/2019
Date results information initially provided
10/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 500 mg tranexamic acid tablet against the innovator 500 mg tranexamic acid tablet conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of 500 mg tranexamic acid tablet in a 2 way crossover comparison against the innovator 500 mg tranexamic acid tablet conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 287430 0
None
Universal Trial Number (UTN)
U1111-1173-4359
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence study conducted in healthy volunteers comparing two formulations of tranexamic acid 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, tranexamic acid is a haemostatic agent used to prevent excessive bleeding in patients with hereditary angioedema. It is also indicated for the short-term treatment of traumatic hyphaema, patients with coagulopathies undergoing minor surgery and menorrhagia. Administration by IV is used for reduction of peri/ postoperative blood loss, need for blood transfusion in cardiac surgery (adults, paediatric), total knee and hip arthroplasty (adults).
296145 0
Condition category
Condition code
Other 296418 296418 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 over study design whereby each participant receives the test formulation of tranexamic acic (1 x 500 mg) on one occasion and the innovator formulation of tranexamic acic (1 x 500 mg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of tranexamic acid.

Each dose (1 x 500 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 13 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.

Screening laboratory tests (including HIV, Hepatitis and drugs of abuse testing), and post study laboratory tests will be completed to assess the health of participants.
Intervention code [1] 292791 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover over study design whereby each participant receives the test formulation of tranexamic acid (1 x 500 mg) on one occasion and the innovator formulation of tranexamic acid (1 x 500 mg) on one occasion with each dose seperated by a one week washout period. The comparator/control for this trial is the innovator formulation of tranexamic acid.
Control group
Active

Outcomes
Primary outcome [1] 296050 0
To compare the bioavailability of tranexamic acid (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for tranexamic acid using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 296050 0
0, 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 4.5, 5, 6, 7, 8, 10 and 13 hours post drug administration
Secondary outcome [1] 317356 0
Time to maximum peak concentration (Tmax). Tmax will be the time where the maximum concentration occurred in the sample points. All plasma samples will be assayed for tranexamic acid using a fully validated LC/MS/MS method.
Timepoint [1] 317356 0
0, 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 4.5, 5, 6, 7, 8, 10 and 13 hours post drug administration
Secondary outcome [2] 317357 0
The elimination half life (t1/2). T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. All plasma samples will be assayed for tranexamic acid using a fully validated LC/MS/MS method.
Timepoint [2] 317357 0
0, 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 4.5, 5, 6, 7, 8, 10 and 13 hours post drug administration

Eligibility
Key inclusion criteria
Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33
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
History of or family history of thromboembolic disease such as deep vein thrombosis (DVT), pulmonary embolism and cerebral thrombosis, antithrombin III deficiency or Factor V Leiden mutation.
Any acquired colour vision disturbance.
Pregnant or breast-feeding
Sensitivity to tranexamic acid or any excipients of tranexamic acid
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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 generator).
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] 7149 0
New Zealand
State/province [1] 7149 0
Otago

Funding & Sponsors
Funding source category [1] 292005 0
Commercial sector/Industry
Name [1] 292005 0
Southern Cross Pharma Pty Ltd
Address [1] 292005 0
56 Illabunda Drive
Malua Bay
NSW 2536
Country [1] 292005 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
PO Box 1777
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 290673 0
None
Name [1] 290673 0
Address [1] 290673 0
Country [1] 290673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293493 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293493 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 293493 0
New Zealand
Date submitted for ethics approval [1] 293493 0
Approval date [1] 293493 0
07/09/2015
Ethics approval number [1] 293493 0
15/NTB/158

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 500 mg tranexamic acid tablet relative to that of the reference formulation (innovator brand of 500 mg tranexamic acid tablet) following oral administration of a single dose of 500 mg in healthy male and female subjects under fasting conditions
Trial website
Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
Public notes

Contacts
Principal investigator
Name 60134 0
Dr Noelyn Hung
Address 60134 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 60134 0
New Zealand
Phone 60134 0
+6434779669
Fax 60134 0
+6434779605
Email 60134 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 60135 0
Mrs Linda Folland
Address 60135 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 60135 0
New Zealand
Phone 60135 0
+6434779669
Fax 60135 0
+6434779605
Email 60135 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 60136 0
Dr Cheung Tak Hung
Address 60136 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 60136 0
New Zealand
Phone 60136 0
+6434779669
Fax 60136 0
+6434779605
Email 60136 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
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 other documents available
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