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Trial registered on ANZCTR


Registration number
ACTRN12614000990628
Ethics application status
Approved
Date submitted
10/09/2014
Date registered
15/09/2014
Date last updated
2/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a single oral dose of beclomethasone dipropionate in healthy male and female volunteers with and without concurrent oral charcoal blockade.
Scientific title
A single dose, randomized, open label, crossover comparative bioavailability study of beclomethasone dipropionate in healthy male and female volunteers under fasting conditions with and without concurrent oral charcoal blockade.
Secondary ID [1] 285306 0
None
Universal Trial Number (UTN)
U1111-1160-5894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioavailability study conducted in healthy volunteers comparing beclomethasone dipropionate administered with and without concurrent charcoal dosing 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, beclomethasone dipropionate belongs to a class of medicines called synthetic corticosteroids. It is used for the treatment of symptoms of seasonal allergic rhinitis including hay fever.
293011 0
Condition category
Condition code
Other 293284 293284 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 formulation of beclomethasone dipropionate (1 x 2000 mcg) on one occasion with oral charcoal administered pre-dose and at specified times up to 4 hours post dosing and on one occasion without oral charcoal with each dose separated by a one week washout period. The intervention for this trial is beclomethasone dipropionate with and without charcoal.

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 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.

Vital sign examination, assessment of well-being, a throat examination, alcohol breath testing, drug testing and pregnancy 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 healthy of participants along with HIV, Hepatitis and drugs of abuse testing.

The volunteer's randomsied to receive 50 ml of activated charcoal suspension will be given the charcoal suspension 2 minutes prior to dosing, immediately with dosing and also at 1, 2 and 4 hours post dosing.

Each dose (1 x 2000 mcg) will be taken orally as 2 ml of beclomethasone dipropionate nasal spray suspension in 18 ml of water. Medication will be administered via a 30 ml syringe and a mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 290215 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives beclomethasone dipropionate (1 x 2000 mcg) with concurrent oral charcoal on one occasion and beclomethasone dipropionate (1 x 2000 mcg) on one occasion without oral charcoal with each dose separated by a one week washout period. The comparator/control for this trial is beclomethasone dipropionate with and without charcoal.
Control group
Active

Outcomes
Primary outcome [1] 293121 0
To compare the bioavailability of beclomethasone dipropionate and 17-BMP (as summarised by Cmax and AUC) with and without concurrent oral charcoal. All plasma samples will be assayed for beclomethasone dipropionate using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 293121 0
0, 0.08, 0.025, 0.50, 0.75, 1, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours
Secondary outcome [1] 310409 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] 310409 0
0, 0.08, 0.025, 0.50, 0.75, 1, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 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, pulse, heart rate, temperature, well-being assessment 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 COPD, chronic bronchitis, emphysema, asthma , or any other lung disease, recent upper or lower respiratory tract infection, migraine headaches
Concomitant drug therapy of any kind
Who have taken any drug that induces/inhibits the hepatic microsomal enzymes within 30 days prior to dosing
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 beclomethasone dipropionate any other similar class medicines or the excipients of beclomethasone dipropionate
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
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.

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 two-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] 6344 0
New Zealand
State/province [1] 6344 0
Otago

Funding & Sponsors
Funding source category [1] 289928 0
Commercial sector/Industry
Name [1] 289928 0
Cipla Ltd
Address [1] 289928 0
Cipla House
Peninsula Business Park
Ganpatrao Kadam Marg
Lower Parel
Mumbai 400013
Country [1] 289928 0
India
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 288620 0
None
Name [1] 288620 0
Address [1] 288620 0
Country [1] 288620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291645 0
Northern Health and Disability Ethics Committee
Ethics committee address [1] 291645 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 291645 0
New Zealand
Date submitted for ethics approval [1] 291645 0
21/08/2014
Approval date [1] 291645 0
02/09/2014
Ethics approval number [1] 291645 0
14/NTB/130

Summary
Brief summary
The objective of this study is to evaluate the bioavailability of beclomethasone dipropionate in healthy male and female volunteers under fasting conditions with and without concurrent oral charcoal.
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 51310 0
Dr Noelyn Hung
Address 51310 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 51310 0
New Zealand
Phone 51310 0
+6434779669
Fax 51310 0
+6434779605
Email 51310 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 51311 0
Mrs Linda Folland
Address 51311 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 51311 0
New Zealand
Phone 51311 0
+6434779669
Fax 51311 0
+6434779605
Email 51311 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 51312 0
Dr Cheung Tak Hung
Address 51312 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 51312 0
New Zealand
Phone 51312 0
+6434779669
Fax 51312 0
+6434779605
Email 51312 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