Home » Trials » SLCTR/2014/026
A Bioequivalence study on the innovator and a generic brand of enteric coated 200mg tablets of sodium valproate, in healthy volunteers
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SLCTR Registration Number
SLCTR/2014/026
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A Bioequivalence study on the innovator and a generic brand of enteric coated 200mg tablets of sodium valproate, in healthy volunteers
Public Title of Trial
A Bioequivalence study of a generic brand of enteric coated sodium valproate tablets
Disease or Health Condition(s) Studied
None
Scientific Acronym
None
Public Acronym
None
Brief title
A bioequivalence study of sodium valproate tablets
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-14-010 (Ethics Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is there a difference between the rate and extent of absorption of generic brand of sodium valproate, Epilex 200mg given to patients through the Ministry of Health hospitals in Sri Lanka in 2014 compared to its reference formulation Epilim 200mg?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Crossover
Purpose
Other
Study Phase
Phase 4
Intervention(s) planned
Healthy volunteers will be recruited using ERC approved advertisements displayed in the Faculty of Medicine, Colombo and NHSL. The sequence of administration will be determined by the pre generated random allocation of the participants to the two arms.
Arm 1: Epilex 200mg manufactured by Akums Pharmaceuticals, India Arm 2: Epilim 200mg manufactured by Sanofi Aventis, UK
Participants of each arm will receive a single dose (200mg) of the interventional product. Following a wash out period of two weeks, there will be a crossover and participants will receive a singledose (200mg) of the second interventional product.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Pharmacokinetics of vaproic acid of the two pro ducts using a validated HPLC method |
[ Serial blood samples taken within 24 hours ] |
Secondary outcome(s)
|
1.
Safety of the products as determined by 1. FBC 2. Serum Creatinine 3. SGOT/SGPT 4. Serum Bilirubin 5. FBS 6. Pregnancy test (in female subjects) |
[ At baseline and at the end of second phase ] |
Target number/sample size
24
Countries of recruitment
Sri Lanka
Anticipated start date
2014-10-16
Anticipated end date
2014-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University of Colombo doctoral research grant –(AP/03/ 2011/PG/12)
Regulatory approvals
Status
Approved
Date of Approval
2014-04-24
Approval number
EC-14-010
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
Priyadarashani Galappatthy
Professor
Department of Pharmacology, Faculty of Medicine, University of Colombo
011-2695300 ext 198
0718655651
011-2697483
priyadarshani1232000@yahoo.com
Contact Person for Public Queries
Uthpali Mannapperuma
lecturer
Department of Pharmacology, Faculty of Medicine, University of Colombo
011-2695300 ext 198
0772873242
011-2697483
uthpalim@yahoo.com
Primary study sponsor/organization
University of Colombo
College House, Cumaranathunga Munidasa Mawatha, Colombo 3
0012581835
0112586059
acpb@admin.cmb.ac.lk
www.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
