Results of bioequivalence studies on the drugs gestodene+ethinylestradiol and drospirenone+ethinylestradiol in healthy volunteers

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Abstract

The paper presents the results of three bioequivalence studies on drugs PlanyGens gesto 20 (gestoden 0.075 mg + ethinylestradiol 0.02 mg), PlanyGens gesto 30 (gestoden 0.075 mg + ethinylestradiol 0.03 mg), PlanyGens drospi (drospirenone 3 mg + ethinylestradiol 0.03 mg) produced by “Pharmasyntez-Tyumen” LLC, Russia and relevant original (reference) drugs Logest (Bayer Pharma AG, Germany), Femoden (Bayer Pharma AG, Germany) and Yarina (Bayer Pharma AG, Germany). During the bioequivalence studies, the pharmacokinetic parameters of gestodene+ethinylestradiol and drospirenone+ethinylestradiol were determined in the blood plasma of healthy volunteers after a single oral intake of the compared drugs on an empty stomach according to an open randomized cross-scheme in two stages. The concentration of gestodene+ethinylestradiol and drospirenone+ethinylestradiol in blood plasma was analyzed with the help of bioanalytic method using highly sensitive and selective high-performance liquid chromatography with tandem mass spectrometric detection. The following pharmacological parameters were calculated for the analyzed drugs: AUC0-72, AUC0-∞, Cmax, Tmax, T½, kel, f’, f’’, Cmax/AUC, MRT. The 90% confidence intervals for the ratio of the geometric mean AUC0-t and Cmax parameters lay in the range of 80.00–125.00% in bioequivalence studies of drugs.

Conclusion: The findings led to the conclusions about the bioequivalence of the test and reference drugs gestodene+ethinylestradiol and drospirenone+ethinylestradiol. The safety profiles of the compared drugs were comparable.

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About the authors

Madina R. Dumanovskaya

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Author for correspondence.
Email: m_dumanovskaya@oparina4.ru
ORCID iD: 0000-0001-7286-6047

PhD, Researcher at the Department of Gynecological Endocrinology

Russian Federation, Moscow

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