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Trial registered on ANZCTR


Registration number
ACTRN12615000073505
Ethics application status
Approved
Date submitted
17/12/2014
Date registered
28/01/2015
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 tiotropium test product 1 and tiotropium test product 2 against the innovator Spiriva HandiHaler conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, open label, bioavailability study of tiotropium test product 1 and tiotropium test product 2 in a 3 way crossover comparison against the innovator Spiriva HandiHaler conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 285853 0
None
Universal Trial Number (UTN)
U1111-1164-8001
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioavailability study conducted in healthy volunteers comparing three formulations of tiotropium with no health condition or problem studied.

Tiotropium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic and is used to make breathing easier for people with Chronic Obstructive Pulmonary Disease (COPD).
293766 0
Condition category
Condition code
Other 294069 294069 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 tiotropium test formulation 1 on one occasion, tiotropium test formulation 2 on one occasion and the innovator formulation of Spiriva HandiHaler on one occasion with each dose separated by a 21 day washout period. The intervention for this trial is the test formulation of tiotropium.

No water is allowed for 1 hour prior to dosing until 2 hours after dosing. 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 10 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 , urine dipstick pregnancy testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site at least 10 hours prior to dosing.

Pre and post study laboratory, oximetry and spirometry tests will be completed to assess the health of participants along with HIV, Hepatitis, serum pregnancy, RPR and drugs of abuse testing.

Each dose will be inhaled using an inhaler. Each subject will be trained on the correct use of the inhaler using empty training devices.

Due to the commercially sensitive nature of this study the Sponsor company has requested that the doses to be administered are not disclosed.
Intervention code [1] 290832 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation tiotropium test 1 and tiotropium test 2 on one occasion and the innovator formulation of Spiriva HandiHaler on one occasion with each dose separated by a 21 day washout period. The comparator/control for this trial is the innovator formulation of Spiriva HandiHaler.
Control group
Active

Outcomes
Primary outcome [1] 293853 0
To compare the bioavailability of tiotropium (as summarised by Cmax and AUC) for the three formulation. All plasma samples will be assayed for tiotropium using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 293853 0
0, 0.03, 0.05, 0.08, 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours
Secondary outcome [1] 311991 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] 311991 0
0, 0.03, 0.05, 0.08, 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours

Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 45
Non-smoker
BMI between 18.5 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, spirometry, oximetry and laboratory tests
Able to provide written informed consent
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, COPD, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to tiotropium or any other similar class of medicines, or the excipients of tiotropium
Who have a history of known allergy to milk protein or food allergy
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
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 T1, T2 or R. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced three-way crossover design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Bio-availability
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] 6550 0
New Zealand
State/province [1] 6550 0
Otago

Funding & Sponsors
Funding source category [1] 290427 0
Commercial sector/Industry
Name [1] 290427 0
Cipla Limited
Address [1] 290427 0
Cipla House
Peninsula Business Park
GanpatraoKadam Marg
Lower Parel
Mumbai 40013
Country [1] 290427 0
India
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 289139 0
None
Name [1] 289139 0
Address [1] 289139 0
Country [1] 289139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292109 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292109 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 292109 0
New Zealand
Date submitted for ethics approval [1] 292109 0
02/12/2014
Approval date [1] 292109 0
22/12/2014
Ethics approval number [1] 292109 0
14/STH/210

Summary
Brief summary
The objective of this study is to compare the rate and extent of absorption of tiotropium test 1 and test 2 with the reference product, Spiriva HandiHaler administered using the HandiHaler device in healthy adult human 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 53562 0
Dr Noelyn Hung
Address 53562 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin
9054
Country 53562 0
New Zealand
Phone 53562 0
+6434779669
Fax 53562 0
+6434779605
Email 53562 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 53563 0
Mrs Linda Folland
Address 53563 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin
9054
Country 53563 0
New Zealand
Phone 53563 0
+6434779669
Fax 53563 0
+6434779605
Email 53563 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 53564 0
Dr Cheung-Tak Hung
Address 53564 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin
9054
Country 53564 0
New Zealand
Phone 53564 0
+6434779669
Fax 53564 0
+6434779605
Email 53564 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