Home » Trials » SLCTR/2007/003
Screening brain targeted novel transcranial drug delivery in human volunteers
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SLCTR Registration Number
SLCTR/2007/003
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Screening brain targeted novel transcranial drug delivery in human volunteers
Public Title of Trial
Study of a novel route of brain targeted drug delivery in human volunteers
Disease or Health Condition(s) Studied
New route of brain targeted drug delivery using diazepam
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/07/001 (Ethical Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Brain targeted drug delivery to avoid systemic side effects ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Crossover
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Assessment of sedative effect of diazepam using clinical criteria and EEG after application of the drug in oil solution
Inclusion criteria
Healthy volunteers below 50 years with normal EEGs and not under any drug therapy which produce sedative effects or EEG changes
Exclusion criteria
Volunteers above 50 years, abnormal EEGs and those under drugs which cause sedation or EEG changes
Primary outcome(s)
|
1.
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[] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
6-7
Countries of recruitment
Sri Lanka
Anticipated start date
2007-03-16
Anticipated end date
2007-05-16
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Improving Relavant and Quality of Undergraduate Education (IRQUE) Project
Regulatory approvals
Status
Approved
Date of Approval
Approval number
EC/07/001
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
W. Pathirana
Senior Lecturer in Pharmacy
Department of Pharmacology,
Faculty of Medicine, University of Colombo
Kynsey Road, Colombo 08
+94 112691111 Ext. 805
+94 112828314
priyanip@hotmail.com
Contact Person for Public Queries
W. Pathirana
Senior Lecturer in Pharmacy
Department of Pharmacology,
Faculty of Medicine, University of Colombo
Kynsey Road, Colombo 08
+94 112691111 Ext. 805
+94 112828314
priyanip@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Yes
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
