Healthy Subject Levetiracetam, Bioequivalence
Conditions
Interventions
reference product of levetiracetam,test product of levetiracetam
Active Comparator Drug,Experimental Drug
Keppra 500 mg,Levetiracetam (Test) product
Sponsors
T.O. Chemicals (1979) Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male/Female must be 18-55 years of age, body mass index (BMI) = 18.0-25.0 kg/m2, inclusive. 2. Must be in good health 3. Screening ECG without clinically significant abnormalities 4. Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr) analysis and liver function test (aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of clinical investigator. 5. Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator. 6. Must have serum hepatitis B surface antigen (HBsAg) seronegative and hepatitis C antibody (anti-HCV) negative. 7. Non-smokers (never smoked or no smoking within the previous 1 year). 8. Subjects must have ended any medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow up period. 9. Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to levetiracetam and its components 2. Past medical history of renal and hepatic insufficiency. 3. Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. 7. Have positive alcohol breathing test at screening visit or before dose administration at each period. 8. Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levetiracetam level in plasma 21 time points in 32 hours after dosing Pharmacokinetic parameters: AUC0-t, AUCinf, Cmax, tmax, t1/2 of levetiracetam | — |
Countries
Thailand
Contacts
Public ContactAriya Khunvichai
Medica Innova Co., Ltd.
Outcome results
None listed