A Bioequivalence study on the innovator and a generic brand of enteric coated 200mg tablets of sodium valproate, in healthy volunteers

niversity of Colombo0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversity of Colombo