Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000525684
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
26/09/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I Study to Determine the Pharmacokinetics of Buspirone from a Metered Dose Transdermal System (MDTS) in anxiety
Scientific title
A Phase I Study to Determine the Pharmacokinetics of Buspirone from a Metered Dose Transdermal System (MDTS) in anxiety
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 650 0
Condition category
Condition code
Mental Health 723 723 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Buspirone Metered Dose Transdermal System (MDTS) and BuSpar up to 5 days.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 885 0
Pharmacokinetic parameters
Timepoint [1] 885 0
On days 1 - 5 of each period
Secondary outcome [1] 1749 0
None
Timepoint [1] 1749 0

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 804 0
Commercial sector/Industry
Name [1] 804 0
Acrux DDS Pty Ltd
Country [1] 804 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 663 0
None
Name [1] 663 0
None
Address [1] 663 0
Country [1] 663 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36045 0
Address 36045 0
Country 36045 0
Phone 36045 0
Fax 36045 0
Email 36045 0
Contact person for public queries
Name 9703 0
Karen Gard'ner
Address 9703 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9703 0
Australia
Phone 9703 0
+61 3 83790100
Fax 9703 0
Email 9703 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 631 0
Andrew Humberstone
Address 631 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 631 0
Australia
Phone 631 0
+61 3 83790100
Fax 631 0
Email 631 0
andrew.humberstone@acrux.com.au

No information has been provided regarding IPD availability


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.