NDLI: Evaluation of the food effect on a drospirenone only contraceptive containing 4 mg administered with and without high-fat breakfast in a randomised trial

Content Provider	Springer Nature : BioMed Central
Author	Regidor, P.-A. Richter, W. H. Koytchev, R. Kirkov, V. Colli, E.
Abstract	Background The objective of the present trial was to assess the difference in pharmacokinetics (PK) of an oral test preparation containing 4 mg drospirenone (DRSP) under fasting conditions compared to PK upon food intake after single dose administration. Methods Open label, single centre, two-treatment, two-sequence, crossover study in 24 healthy female volunteers, with duration of 1 day per sequence and with a real wash-out period of 14 days 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; 0–72 h [AUC(0-72 h)] and maximal plasma concentration [Cmax] of DRSP. Results The 90% CI calculated by analysis of variance using logistic transformation (ANOVA-log) for the endpoint, intra-individual ratio (Test ‘A’ = with food intake) vs. Test ‘B’ = without food intake) of AUC(0-72 h) 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 ‘A’ vs. Test ‘B’) of Cmax of DRSP was between 118.58 and 141.10%. The mean relative bioavailability of the test with food ‘A’ compared to the Test without food ‘B’ after single dose administration based on the endpoints AUC(0-72 h) was 107.99%; for the endpoint Cmax it was 129.35%. Conclusions 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. Implications Our results suggest that the food intake has no impact on the absorption of 4 mg 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. Trail registration: Trial registration number: EudraCT-No: 2012–004,309-28.
Related Links	https://bmcwomenshealth.biomedcentral.com/counter/pdf/10.1186/s12905-022-01960-2.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	14726874
DOI	10.1186/s12905-022-01960-2
Journal	BMC Women's Health
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2022-09-19
Access Restriction	Open
Subject Keyword	Gynecology Maternal and Child Health Reproductive Medicine Drospirenone Bioavailability Pharmacokinetic Food intake
Content Type	Text
Resource Type	Article
Subject	Obstetrics and Gynecology Reproductive Medicine
Journal Impact Factor	2.4/2023
5-Year Journal Impact Factor	2.9/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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