Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000776202
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
9/05/2018
Date last updated
11/10/2021
Date data sharing statement initially provided
11/10/2021
Date results information initially provided
11/10/2021
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 in healthy male and female volunteers.
Scientific title
A single 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 in healthy male and female volunteers.
Secondary ID [1] 294818 0
Nil
Universal Trial Number (UTN)
U1111-1208-8178
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). 307749 0
Condition category
Condition code
Renal and Urogenital 306805 306805 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 0.4 mg tamsulosin tablet on one occasion and the innovator formulation of 0.4 mg tamsulosin tablet 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. 0.4 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] 301131 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study 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 one week washout period. The comparator/control for this trial is the innovator tablet formulation.
Control group
Active

Outcomes
Primary outcome [1] 305795 0
To compare the bioavailability of tamsulosin (as summarised by Cmax and AUC) for the formulation. 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] 305795 0
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 32, 48 and 56 hours post dosing
Secondary outcome [1] 346575 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] 346575 0
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 24, 32, 48 and 56 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
14/05/2018
Actual
18/05/2018
Date of last participant enrolment
Anticipated
Actual
18/05/2018
Date of last data collection
Anticipated
Actual
29/05/2018
Sample size
Target
28
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 10383 0
New Zealand
State/province [1] 10383 0
Otago

Funding & Sponsors
Funding source category [1] 299416 0
Commercial sector/Industry
Name [1] 299416 0
Southern Cross Pharma Pty Ltd
Country [1] 299416 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] 298702 0
None
Name [1] 298702 0
Address [1] 298702 0
Country [1] 298702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300316 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 300316 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 300316 0
New Zealand
Date submitted for ethics approval [1] 300316 0
13/02/2018
Approval date [1] 300316 0
05/03/2018
Ethics approval number [1] 300316 0
18/NTA/20

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 0.4 mg tamsulosin tablet to healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83270 0
Dr Noelyn Hung
Address 83270 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 83270 0
New Zealand
Phone 83270 0
+6434779669
Fax 83270 0
+6434779605
Email 83270 0
[email protected]
Contact person for public queries
Name 83271 0
Mrs Linda Folland
Address 83271 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 83271 0
New Zealand
Phone 83271 0
+6434779669
Fax 83271 0
+6434779605
Email 83271 0
[email protected]
Contact person for scientific queries
Name 83272 0
Dr Tak Hung
Address 83272 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 83272 0
New Zealand
Phone 83272 0
+6434779669
Fax 83272 0
+6434779605
Email 83272 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


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.