Bioequivalence study Topiramate,
Conditions
Interventions
single dose of topiramate at the dose of 100 mg,single dose of topiramate at the dose of 100 mg
Experimental Drug,Experimental Drug
Macromax 100,Topamax® (100 mg)
Sponsors
Siriraj Clinical Research Center
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Thai male age between 18-45 years 2. Has body mass index (BMI) between 18.0-25.0 kg/m2 3. Has been determined healthy by physical examination, assessment of drug abuse, medical history, and vital signs 4. Has normal or acceptable results (being assessed as clinically non-significant by the clinical investigator) for all screening tests including: complete blood count (CBC), fasting blood sugar (FBS), aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP), total bilirubin, blood urea nitrogen (BUN), serum creatinine (Cr) and urinalysis 5. Has negative result for hepatitis B viral profile (HBsAg) 6. Has normal or acceptable report (being assessed as clinically non-significant by the clinical investigator) for EKG 7. Using effective contraception after the first dosing and continue until 7 days after the end of study 8. Has ability and intention to comply with the requirement of study and available for the whole study period 9. Willing to participate and voluntarily signed the informed consent form prior to participate the study
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction to topiramate and/or related structure and/or its constituents. 2. Has 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. Regularly alcohol consumption (more than 1 time/week) and cannot abstain for at least 3 days prior to dosing. 4. Alcohol breath test before admission show alcohol concentration more than 0 mg%. 5. A smoker or non-smoker less than 30 days 6. Use of any drugs (except paracetamol) especially which can affect cytochrome P450 enzymes (enzyme inducers e.g., phenobarbital, phenytoin, rifampicin and/or enzyme inhibitors e.g., cimetidine, ketoconazole, erythromycin) within 14 days prior to the first dosing and willing to taking them throughout participation period 7. Use of paracetamol within 3 days prior to dosing and until after the last sample is collected in each period (Paracetamol taken during this prohibition period can be approved under the consideration of principal investigator or clinical investigator) 8. Use of food supplements, vitamins, minerals and/or herbal remedies within 14 days before the first dosing and willing to taking them throughout participation period 9. Has drink containing xanthine derivatives or xanthine-related compounds (e.g. coffee, tea, colas, chocolate, caffeine-containing sodas and decaffeinated products) for at least 3 days prior to dosing and until after the last sample is collected in each period. 10. Has drink or food containing grapefruit and/or orange and/or pomegranate compound for at least 3 days prior to dosing and until after the last sample is collected in each period. 11. Following a special diet (e.g., vegetarian) or dieting one month before the study initiation. 12. Has history of problem in swallowing tablet 13. A participant in other clinical studies within last 30 days prior to the first dosing 14. Has blood donated and/or blood loss more than 350 mL within last 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence 6 month 90% geometric confidence interval of Cmax, AUC0-t and AUC0-inf | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters 6 months Cmax and Tmax are taken directly from the individual concentration versus time data. | — |
Countries
Thailand
Contacts
Public Contactsomruedee Chatsiricharoenkul
Siriraj Clinical Research Center
Outcome results
None listed