None
Conditions
Interventions
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 ra
Sponsors
University of Colombo
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-45 years. 2. Body mass index (BMI) between 18-25 kg/m2 3. Determined healthy by physical examination, assessment of drug abuse, medical history, and vital signs. 4. Normal or acceptable results for the following screening tests: • Complete blood count • Fasting blood glucose • Liver and kidney function tests • Urine analysis 5. Non-pregnant woman (negative pregnancy test) or using appropriate contraceptive method or currently not breast feeding
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions or allergy to sodium valproate and/or its constituents 2. History or concurrent symptoms of allergy, cardiovascular, liver, kidney, gastrointestinal, hematological disorders and/or any disease that may affect the bioavailability of the drug 3. Regular alcohol consumption (more than 1 time/week) or drug addict 4. Smoker or ex-smoker less than 30 days 5. Use of any drugs within 14 days prior to administrating the first study drug and willing to take them throughout the participation period. 6. Use of food supplements taken as capsules or tablets or nutraceuticals, vitamins, mineral, herbal remedies and/or hormonal contraceptives within 14 days before first study drug administration and willing to taking them throughout participation period 7. Participation in other clinical studies within last 30 days 8. Pregnant (positive pregnancy test) or breast feeding 9. Blood donation within last 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of vaproic acid of the two pro ducts using a validated HPLC method [Serial blood samples taken within 24 hours] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ] | — |
Countries
Sri Lanka
Contacts
Public ContactPriyadarashani Galappatthy
Professor
Outcome results
None listed