Pharmaceutica Analytica Acta

Bioequivalence study of Levofloxacin in healthy Kazakhs volunteers

2^nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

2011

Shnaukshta V.S

National Centre for Expertise of Drugs, Medical Products and Equipment of the Ministry of Health, Republic of Kazakhstan

Scientific Tracks Abstracts: Pharm Anal Acta

Abstract:

Levofl oxacin is a synthetic chemotherapeutic antibiotic drug which is used for treatment of bacterial infections. Th ere are many Levofl oxacin generic drugs in Kazakhstan and relative bioavailability is important as it shows the drug quality. Th erefore has been studied BA/BE of the test formulation Levolet (T) and reference formulation Tavanic (R) containing of Levofl oxacin 500 mg tablets aft er single dose oral administration under fasting condition. Volunteers were healthy Kazakh adults randomly assigned to receive T- and R- formulation or vs. with a 1-week washout period between doses. A total of 18 participants were enrolled including 7 men and 11 women at the age of 28 years (range 19-40 years). Levofl oxacin plasma concentrations were determined by HPLS assay using UV detection. For the analysis of pharmacokinetic parameters, including Cmax, AUC0-24, AUC0-∞ and Cmax/ AUC0−24, blood samples were collected at baseline and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours aft er oral administration of the drugs. Th e test formulations were considered to meet the criteria for bioequivalence if the geometric mean ratios (T/R) were in the range of 80% to 125%. Mean relative bioavailability was 100.3%. Th e 90% CIs of the mean of the diff erence between log-transformed values for Cmax, AUC0-24 and AUC0- ∞ were 93.3% to 104%, 93% to 105% and 91% to 107%, respectively. Th is study shows that there is no signifi cant diff erence in kinetic parameters between two products. Th erefore, these two formulations are considered to be bioequivalent.

Biography :

Shnaukshta Valentina graduated from Karaganda State University with a specialization in Chemistry. She has worked in the Pharmacology Research Institute (Moscow) and got PhD in biology at the age of 33. She has the research works in the sphere of psychotropic drugs pharmacology. She has been working as a professor of pharmacology at the Karaganda State Medical Academy for 7 years. During 6 years for present time she is the head of the pharmacological research laboratory in the state expert organization of the Republic of Kazakhstan. She has more than 10 publications in the fi eld of pharmacokinetic studies and takes part in preclinical and clinical studies of medical drugs and pharmacokinetic bioequivalence studies.