Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001147279
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
12/07/2018
Date last updated
26/10/2021
Date data sharing statement initially provided
26/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of tamsulosin tablet against the innovator tamsulosin tablet conducted under fasting condition and at steady state in healthy male and female volunteers.
Scientific title
A multiple dose, randomized, blinded, bioequivalence study of a test formulation of tamsulosin tablet in a 2 way crossover comparison against the innovator tamsulosin tablet conducted under fasting conditions and at steady state in healthy male and female volunteers.
Secondary ID [1] 295503 0
None
Universal Trial Number (UTN)
U1111-1208-9111
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tamsulosin is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 308770 0
Condition category
Condition code
Renal and Urogenital 307706 307706 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple dose, crossover study design whereby each participant receives the test formulation of 0.4 mg tamsulosin tablet on five occasions and the innovator formulation of 0.4 mg tamsulosin tablet on five occasions with each dose separated by a 10 day washout period. The intervention for this trial is the test tablet formulation.

On study days 1-5 subjects will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test).

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 4 hours before receiving each dose on study days 1 to 5 and 15 to 19.

On study days 5 and 19 subjects will report to the Zenith Clinical Site for dosing and observation of adverse events and the provision of one blood sample. They are required to stay at the clinical site for 24 hours after dosing.

On study days 1 to 4 and 15 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample.

On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and subjects are required to fast for 8 hours prior to receiving the dose and 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 8 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing.

Standard meals will be consumed at the Clinical Site on study days 5 and 19 with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 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.
Intervention code [1] 301823 0
Treatment: Drugs
Comparator / control treatment
Multiple dose, crossover study design whereby each participant receives the test formulation (1 x 0.4 mg) on one occasion and the innovator formulation of tamsulosin (1 x 0.4 mg) on one occasion with each dose separated by a 10 day washout period. The comparator/control for this trial is the innovator tablet formulation.
Control group
Active

Outcomes
Primary outcome [1] 306696 0
To compare the bioavailability of tamsulosin (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for tamsulosin using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 306696 0
Pre-dose on days 1-4 and 15-18 then on study days 5 and 19 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 hours post dosing
Secondary outcome [1] 349281 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 tamsulosin using a fully validated LC/MS/MS method.
Timepoint [1] 349281 0
Pre-dose on days 1-4 and 15-18 then on study days 5 and 19 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 hours post dosing

Eligibility
Key inclusion criteria
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 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
Concomitant drug therapy of any kind
Any history of orthostatic hypotension.
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
17/07/2018
Actual
17/07/2018
Date of last participant enrolment
Anticipated
Actual
17/07/2018
Date of last data collection
Anticipated
Actual
6/08/2018
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 10636 0
New Zealand
State/province [1] 10636 0
Otago

Funding & Sponsors
Funding source category [1] 300088 0
Commercial sector/Industry
Name [1] 300088 0
Southern Cross Pharma Pty Ltd
Country [1] 300088 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 299489 0
None
Name [1] 299489 0
Address [1] 299489 0
Country [1] 299489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300935 0
Northern A Health & Disability Ethics Committee
Ethics committee address [1] 300935 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 300935 0
New Zealand
Date submitted for ethics approval [1] 300935 0
06/02/2018
Approval date [1] 300935 0
05/03/2018
Ethics approval number [1] 300935 0
18/NTA/22

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to that of a reference formulation, following oral administration of multiple doses of 0.4 mg tamsulosin tablet to healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85334 0
Dr Noelyn Hung
Address 85334 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 85334 0
New Zealand
Phone 85334 0
+6434779669
Fax 85334 0
+6434779605
Email 85334 0
[email protected]
Contact person for public queries
Name 85335 0
Linda Folland
Address 85335 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 85335 0
New Zealand
Phone 85335 0
+6434779669
Fax 85335 0
+6434779605
Email 85335 0
[email protected]
Contact person for scientific queries
Name 85336 0
Tak Hung
Address 85336 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 85336 0
New Zealand
Phone 85336 0
+6434779669
Fax 85336 0
+6434779605
Email 85336 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.

Documents added automatically
No additional documents have been identified.