{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,22]],"date-time":"2026-02-22T01:47:24Z","timestamp":1771724844843,"version":"3.50.1"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,9,19]],"date-time":"2022-09-19T00:00:00Z","timestamp":1663545600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,19]],"date-time":"2022-09-19T00:00:00Z","timestamp":1663545600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Insud Pharma"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Women's Health"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The objective of the present trial was to assess the difference in pharmacokinetics (PK) of an oral test preparation containing 4\u00a0mg drospirenone (DRSP) under fasting conditions compared to PK upon food intake after single dose administration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Open label, single centre, two-treatment, two-sequence, crossover study in 24 healthy female volunteers, with duration of 1\u00a0day per sequence and with a real wash-out period of 14\u00a0days to investigate the relative bioavailability of DRSP with both forms of administration. The 90% confidence intervals (CI) were calculated for the intra-individual ratio (test with food vs. without food) of the PK endpoints Area under the curve; 0\u201372\u00a0h [AUC(0-72\u00a0h<jats:sub>)<\/jats:sub>] and maximal plasma concentration [Cmax] of DRSP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 90% CI calculated by analysis of variance using logistic transformation (ANOVA-log) for the endpoint, intra-individual ratio (Test \u2018A\u2019\u2009=\u2009with food intake) vs. Test \u2018B\u2019\u2009=\u2009without food intake) of AUC(0-72\u00a0h) of drospirenone was between 104.72 and 111.36%. The 90% CI calculated by means of ANOVA- log for the endpoint intra-individual ratio (Test \u2018A\u2019 vs. Test \u2018B\u2019) of Cmax of DRSP was between 118.58 and 141.10%. The mean relative bioavailability of the test with food \u2018A\u2019 compared to the Test without food \u2018B\u2019 after single dose administration based on the endpoints AUC(0-72\u00a0h<jats:sub>)<\/jats:sub>was 107.99%; for the endpoint Cmax it was 129.35%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The rate of absorption, based on the endpoint Cmax of DRSP was increased by about 30% under fed conditions. With respect to consumer habits, this may represent a relevant benefit for contraceptive safety, as the time span between food consumption and pill intake does not play a role.<\/jats:p><\/jats:sec><jats:sec><jats:title>Implications<\/jats:title><jats:p>Our results suggest that the food intake has no impact on the absorption of 4\u00a0mg DRSP in the management of contraception. This increases the contraceptive efficacy as no interference with food is expected when consuming the oral formulation under real life conditions.<\/jats:p><jats:p><jats:italic>Trail registration<\/jats:italic>: Trial registration number: EudraCT-No: 2012\u2013004,309-28.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12905-022-01960-2","type":"journal-article","created":{"date-parts":[[2022,9,19]],"date-time":"2022-09-19T04:02:42Z","timestamp":1663560162000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the food effect on a drospirenone only contraceptive containing 4\u00a0mg administered with and without high-fat breakfast in a randomised trial"],"prefix":"10.1186","volume":"22","author":[{"given":"P.-A.","family":"Regidor","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. 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The Bulgarian Drug Agency and the local ethics committee at MHAT Tokuda Hospital (Sofia, Bulgaria) approved the study, and all subjects gave written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"A written informed consent was obtained from all participants that were enrolled in the clinical trial.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All authors have completed the Unified Competing Interest form. W. Richter, R. Koytchev are employed by Cooperative Clinical Drug Research and Development AG, Hoppegarten, Germany. V. Kirkov is employed at the Sector for Bioequivalence Trials at MHAT Tokuda Hospital Sofia AD, Bulgaria. E. Colli and P.-A. Regidor are employees of Exeltis Healthcare. There are no other financial relationships with any organizations that might have an interest in the submitted work in the previous 3\u00a0years and no other relationships or activities that could appear to have influenced the submitted work.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"381"}}