Evaluation of bioequivalence of two tablet forms of lisinopril in healthy volunteers
Abstract
Under cross, single, open, randomized trial with 1 week washout period, with two sequences of 18 volunteers studied bioequivalence coated tablets, two manufacturers of lisinopril (20 mg dose). The concentration of lisinopril in the plasma samples was determined using HPLC with fluorimetric detection within 72 hours for the investigated preparations the following pharmacokinetic parameters were calculated:AUC0-∞, Cmax, tmax, Cmax/AUC. 90% confidence interval relations AUC0-∞ compared drugs totaled 0.8520 — 1.2102 for Cmax — 0,9288 — 1,1451. In addition to the 90% confidence intervals, analysis of variance revealed no statistically significant differences between the studied drugs. Concluded bioequivalence compared drugs lisinopril.
About the Authors
S. A. Altynbekov
Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction, MoH, Republic of Kazakhstan, Almaty
Russian Federation
Russian Federation
G. A. Dzholdygulov
Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction, MoH, Republic of Kazakhstan, Almaty
Russian Federation
Russian Federation
V. N. Seryakov
Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction, MoH, Republic of Kazakhstan, Almaty
Russian Federation
Russian Federation
Y. M. Budach
JSC «Chimpharm», Republic of Kazakhstan, Almaty
Russian Federation
Russian Federation
O. E. Kurilo
JSC «Chimpharm», Republic of Kazakhstan, Almaty
Russian Federation
Russian Federation
N. I. Kuznetsova
Medical University «First Moscow State University, I.M. Sechenov»
Russian Federation
Russian Federation
References
1. Оценка биоэквивалентности лекарственных средств (Методические рекомендации), Москва, 2008, с.32.
2. Проведение надлежащих исследований биоэквивалентности лекарственных средств в Республике Казахстан, Астана, 2007, с. 44.
3. Сергиенко В.И., Джеллифф Р., Бондарева И.Б. Прикладная фармакокинетика: основные положения и клиническое применение. Москва, Издательство РАМН, 2003; 208.
4. Регистр лекарственных средств России РЛС. Энциклопедия лекарств. Москва, РЛС-Медиа, 2013; 1296.
5. Sagirli O., Ersoy L. An HPLC method for the determination of lisinopril in human plasma and urine with fluorescence detection. // J. Chromatogr. B. 2004, Vol. 809, Р. 159-165.
6. Neng Zhoul, Yi-zeng Liangl, Ben-mei Chen et al. Development and Validation of LC—MS Method for the Determination of Lisinopril in Human Plasma and its Application in a Bioequivalence Study. // Journal of Chromatogr. Sci. 2008, Vol. 46, Р. 848-853.
7. Shin M.C., Kim J.K., Kim C.K. Bioequivalence evaluation of two brands of lisinopril tablets by in vitro comparative dissolution test and in vivo bioequivalence test. // Arzneimittelforschung. 2008, Vol. 58(1), P. 11-17.
8. Tamimi J.J., Salem I.I., Alam S.M., Zaman Q., Dham R. Bioequivalence evaluation of two brands of lisinopril tablets (Lisotec and Zestril) in healthy human volunteers. // Biopharm. Drug Dispos. 2005, Vol. 26(8), P. 335-339.
Review
For citations:
Altynbekov S.A., Dzholdygulov G.A., Seryakov V.N., Budach Y.M., Kurilo O.E., Kuznetsova N.I. Evaluation of bioequivalence of two tablet forms of lisinopril in healthy volunteers. Pharmacokinetics and Pharmacodynamics. 2013;(2):33-36. (In Russ.)
Views:
653
Email this article 