Results of bioequivalence studies on the drugs gestodene+ethinylestradiol and drospirenone+ethinylestradiol in healthy volunteers
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.Dumanovskaya M.R.
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.
Conflicts of interest: The authors declare no possible conflicts of interest.
Funding: The study was conducted without sponsorship.
Acknowledgements: The author expresses gratitude to Irina A. Proskurina, PhD, Head of the Department No. 2 in the Effectiveness and Safety of Drugs, Scientific Centre for Expert Evaluation of Medicinal Products, for assistance in preparing the article.
For citation: Dumanovskaya M.R. Results of bioequivalence studies on the drugs gestodene+ethinylestradiol and drospirenone+ethinylestradiol in healthy volunteers.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (8): 192-202 (in Russian)
https://dx.doi.org/10.18565/aig.2023.194
Keywords
bioequivalence
pharmacokinetic parameters
gestodene+ethinylestradiol
drospirenone+ethinylestradiol
PlanyGens gesto 20
PlanyGens gesto 30
PlanyGens drospi
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Received 21.07.2023
Accepted 16.08.2023
About the Authors
Madina R. Dumanovskaya, PhD, Researcher at the Department of Gynecological Endocrinology, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, m_dumanovskaya@oparina4.ru, https://orcid.org/0000-0001-7286-6047, 117997, Russia, Moscow, Ac. Oparin str., 4.Similar Articles
