Adv Ther (2017) 34:2022–2032 DOI 10.1007/s12325-017-0585-9 ORIGINAL RESEARCH Comparison of the Systemic and Local Pharmacokinetics of Clonidine Mucoadhesive Buccal Tablets with Reference Clonidine Oral Tablets in Healthy Volunteers: An Open-Label Randomised Cross-Over Trial . . . . Be ´range `re Vasseur Alain Dufour Laetitia Houdas Helen Goodwin . . Kathryn Harries Neslihan Yesiltas Emul Simon Hutchings Received: May 30, 2017 / Published online: July 19, 2017 Springer Healthcare Ltd. 2017 subjects aged 18–50 years. Eligibility was assessed ABSTRACT within 14 days of the ﬁrst dose. IMP was admin- istered in the fasted state on day 1 of each treat- Introduction: The clonidine mucoadhesive ment period. PK samples were collected up to buccal tablet (MBT) is a novel delivery system 24 h (saliva)/96 h (blood) for measurement of the resulting in high and sustained concentrations clonidine concentration. Safety and tolerability of clonidine in the oral cavity. In a phase II were evaluated at speciﬁed times throughout the clinical trial, clonidine MBT reduced the inci- study. A washout period of at least 7 days was dence of severe oral mucositis (OM) compared observed between administrations. to placebo in head and neck cancer patients Results: Clonidine MBT (50 and 100 lg) undergoing
Advances in Therapy – Springer Journals
Published: Jul 19, 2017
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