A comparative study of pharmacokinetics of coated tablets of mycophenolic acid
Abstract
In a single-dose, two-treatment, two-period, two-sequence crossover study with a 14-days washout period was carried out the bioequivalence study of two tablet coated formulation of mycophenolic acid that given to 48 volunteers in equal doses (dosage 360 mg). There were calculated the followed parameters: AUC0-t, Cmax, Tmax, Cmax/AUC. 90% confidence interval for ratio of geometric mean AUC0-t values was 98,97% - 111,49% and one for ratio of geometric mean Cmax was 121,27% - 153,94%. The upper limit of the confidence interval of Cmax valuesa goes beyond the permissible range according to the protocol study (75-133%). It is not possible to state bioequivalence of drugs. Possible causes of discrepancies of pharmacokinetic parameters were analyzed.
About the Authors
A. L. Khokhlov
ФГБОУ ВО «Ярославского государственного медицинского университета» МЗ РФ
Russian Federation
Russian Federation
I. I. Yaichkov
ФГБОУ ВО «Ярославского государственного медицинского университета» МЗ РФ
Russian Federation
Russian Federation
A. M. Shitova
ООО «Квинта-АналитикаЯрославль»
Russian Federation
Russian Federation
L. N. Shitov
ФГБОУ ВО «Ярославского государственного медицинского университета» МЗ РФ; ООО «Квинта-АналитикаЯрославль»
Russian Federation
Russian Federation
Yu. A. Dzhurko
ООО «Квинта-АналитикаЯрославль»
Russian Federation
Russian Federation
A. E. Miroshnikov
ФГБОУ ВО «Ярославского государственного медицинского университета» МЗ РФ
Russian Federation
Russian Federation
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Review
For citations:
Khokhlov A.L., Yaichkov I.I., Shitova A.M., Shitov L.N., Dzhurko Yu.A., Miroshnikov A.E. A comparative study of pharmacokinetics of coated tablets of mycophenolic acid. Pharmacokinetics and Pharmacodynamics. 2016;(4):3-8. (In Russ.)
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