An open-label, two-period, crossover study of the systemic bioavailability in healthy women of clindamycin phosphate from two vaginal cream formulations

Clinical Therapeutics
R Saul LevinsonJames L Joffrion

Abstract

A clindamycin phosphate 2% single-dose vaginal cream (CSDVC) formulation has been designed to provide release of clindamycin equivalent to 7 daily doses of a conventional clindamycin phosphate 2% vaginal cream (CVC). The purpose of this study was to compare the systemic bioavailability of clindamycin from 1 dose of CSDVC with that from 1 dose from a 7-day regimen of CVC in healthy women. This was a single-center, open-label, randomized, 2-period, 2-sequence crossover study that enrolled healthy, nonpregnant, adult women. Subjects were randomly assigned to receive a single 5-g intravaginal dose of CSDVC or CVC. Blood samples were then collected for 96 hours after study medication administration. Subjects were crossed over after a 14-day washout period, and received a single dose of the other medication. Blood samples were then collected for 96 hours after administration of the second drug. The plasma clindamycin pharmacokinetic profiles were determined, using a validated assay with a lower limit of detection of 0.2 ng/mL, and compared between treatments. The median age of women was 43.5 years(range, 18-66 years), the median weight was 65.0 kg (range, 47.7-91.8 kg), and the median body mass index was 25.4 kg/m2 (range, 19.2-34.7 ...Continue Reading

References

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Nov 22, 2005·Expert Opinion on Drug Delivery·Jennifer MerabetR Saul Levinson

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Citations

May 17, 2011·APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica·Katarina ErikssonUrban Forsum
Dec 11, 2013·Pharmaceutical Development and Technology·Laila H EmaraNadia M Mursi
Jan 25, 2008·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·José das NevesJorge Brochado
Jul 28, 2016·Clinical and Translational Medicine·Maria Longauer BanholzerLucette Doessegger

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