Results of bioequivalence studies on the oral contraceptives levonorgestrel+ethinylestradiol, desogestrel+ethinylestradiol and nomegestrol+estradiol in healthy volunteers
Dumanovskaya M.R.
Currently, import substitution of medications is one of the priorities of the state policy in the field of healthcare. One of the main criteria for evaluating a generic medication is confirmation of its bioequivalence to the relevant original drug.
Objective: To study the comparative pharmacokinetics and evaluate the bioequivalence of the generic contraceptive drugs PlanyGens in healthy female volunteers after a single oral intake of the drugs on an empty stomach.
Materials and methods: It is an open comparative randomized cross-sectional study with two stages and two subsequent studies. The pharmacokinetic parameters of levonorgestrel, etonogestrel (the active metabolite of desogestrel), nomegestrol, ethinylestradiol and estradiol were determined in the blood plasma of healthy volunteers after a single oral intake of the compared drugs on an empty stomach. The following pharmacological parameters were calculated for the analyzed drugs: AUC0–72, AUC0–∞, Cmax, Tmax, T½, kel, f’, f’’, Cmax/AUC, MRT.
Results: The research presents the results of bioequivalence studies on contraceptives PlanyGens levo, PlanyGens dezo 20, PlanyGens dezo 30, PlanyGens nome produced by “Pharmasyntez-Tyumen” LLC, Russia and relevant original (reference) drugs Microgynon (Bayer Pharma AG, Germany), Mercilon (N.V. Organon, Netherlands), Marvelon (N.V. Organon, Netherlands), and Zoely (N.V. Organon, Netherlands). The 90% confidence intervals for the ratio of the geometric mean AUC0–72 and Cmax parameters lay in the range of 80.00–125.00% in bioequivalence studies of drugs. The safety profiles of all the studied drugs are comparable to the safety profiles of the relevant original drugs.
Conclusion: The bioequivalence of the studied generic contraceptive drugs PlanyGens to the relevant original drugs was confirmed.
Conflict of interest: The author declares 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 oral contraceptives levonorgestrel+ethinylestradiol, desogestrel+ethinylestradiol and nomegestrol+estradiol in healthy volunteers. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (11): 180-192 (in Russian)
https://dx.doi.org/10.18565/aig.2023.258
Keywords
import substitution
generic drugs
bioequivalence study
combined oral contraceptives
levonorgestrel+ethinylestradiol
desogestrel+ethinylestradiol
nomegestrol+estradiol
PlanyGens levo
PlanyGens dezo 20
PlanyGens dezo 30
PlanyGens nome
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Received 23.10.2023
Accepted 14.11.2023
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.
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