A comparative bioequivalence study to evaluate the pharmacokinetic profile and safety of single-dose of dydrogesterone 10 mg tablets in healthy adult female volunteers


  • Akhilesh D. Sharma Alkem Laboratories, Mumbai, Maharashtra, India
  • Anindita Chatterjee Department of Medical Affairs, Alkem Laboratories, Mumbai, Maharashtra, India
  • Radhakrishna Vaddem Department of Bioequivalence, Alkem Laboratories, Mumbai, Maharashtra, India




Bioequivalence, Dydrogesterone, Pharmacokinetic


Background: Dydrogesterone is a progesterone derivative. It is indicated in variety of disorders requiring progesterone administration. The basic aim of this bioequivalence (BE) study was to compare the pharmacokinetic profile of generic dydrogesterone 10 mg tablets (test product- Dydrosure) versus the innovator brand.

Methods: This was a randomized, open-label, balanced, two-treatment, two-period, two-sequence, two-way crossover, single oral dose BE study conducted in healthy adult females under fasting conditions. A total of 28 subjects participated and 27 subjects completed both the study periods with 14 days washout in between. A total of 23 serial blood samples were collected starting from pre-dose to 72-hour post-dose. The primary pharmacokinetic parameters included peak plasma concentration (Cmax), area under the curve from zero to time t (AUC0-t) and zero to infinity (AUC0-inf); and 90% confidence intervals (CIs) of geometric least square mean (LSM) ratio of test product versus reference product were computed to evaluate the BE. The safety evaluation was based on reported adverse events (AEs) and laboratory parameters.

Results: The 90% CIs of geometric LSM ratio of all primary pharmacokinetic parameters were within the range of 80 to 125%. The sequence, period and treatment did not have significant effect on the primary pharmacokinetic parameters. A single AE of dizziness was reported with the test product which was mild in intensity and transient in nature.

Conclusions: Based on the statistical analysis of dydrogesterone, it is concluded that the test product (T): Dydrosure (dydrogesterone tablets IP 10 mg) manufactured by Alkem Laboratories Ltd., India is bioequivalent to the innovator’s brand, in terms of rate and extent of absorption under fasting conditions. The test product can be used interchangeably with the innovator’s brand.


Griesinger G, Blockeel C, Kahler E, Pexman-Fieth C, Olofsson JI, Driessen S, Tournaye H. Dydrogesterone as an oral alternative to vaginal progesterone for IVF luteal phase support: A systematic review and individual participant data meta-analysis. PLoS One. 2020;15(11):e0241044.

Duphaston 10 mg film-coated tablets [Summary of Product Characteristics]. Olst, Abbott Biologicals B.V. 2019.

Duphaston 10 mg film-coated tablets [Prescribing Information]. Tel Aviv, Abbott Medical Laboratories Ltd. 2014.

Duphaston® 10mg Film Coated Tablets [Prescribing Information]. Lahore, Highnoon Laboratories Ltd. 2016.

Indian Council of Medical Research. National ethical guidelines for biomedical and health research involving human participants. 2017. Available at: https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf. Accessed on 12 June 2022.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised Guideline. Integrated Addendum To ICH E6(R1): Guideline for Good Clinical Practice E6(R2). 2016. Available at: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. Accessed on 12 June 2022.

Ministry of Health and Family Welfare (Department of Health and Family Welfare). G.S.R.227(E). New Drugs and Clinical Trials Rules, 2019. 2019. Available at: https://cdsco.gov.in/opencms/export/ sites/CDSCO_WEB/Pdf- documents/NewDrugs_ CTRules_2019.pdf. Accessed on 12 June 2022.

Central Drugs Standard Control Organization. Guidelines for Bioavailability and Bioequivalence studies. 2005. Available at: https://dinesh thakur.com/wp-content/uploads/2016/06/be-guidelines-draft-ver10-march-16-05.pdf. Accessed on 12 June 2022.

Galgatte UC, Jamdade VR, Aute PP, Chaudhari PD. Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada. Saudi Pharm J. 2014;22(5):391-402.

Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for Industry - Statistical Approaches to Establishing Bioequivalence. 2001. Available at: https://www. fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence. Accessed on 12 June 2022.

European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). 2010. Available at: https://www.ema.europa.eu/en/ committees/committee-medicinal-products-human-use-chmp. Accessed on 12 June 2022.




How to Cite

Sharma, A. D., Chatterjee, A., & Vaddem, R. (2022). A comparative bioequivalence study to evaluate the pharmacokinetic profile and safety of single-dose of dydrogesterone 10 mg tablets in healthy adult female volunteers. International Journal of Research in Medical Sciences, 10(10), 2203–2208. https://doi.org/10.18203/2320-6012.ijrms20222524



Original Research Articles