A phase I PK study of clonidine mucoadhesive buccal tablets (MBT)
Research type
Research Study
Full title
A randomised, single dose, 3 way crossover, single blind study to evaluate the pharmacokinetic dose proportionality and compare the bioavailability and safety of clonidine mucoadhesive buccal tablets (MBT) with clonidine hydrochloride tablets (reference product) in normal healthy volunteers.
IRAS ID
181172
Contact name
Simon Hutchings
Contact email
Sponsor organisation
Onxeo
Eudract number
2015-001836-40
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
The purpose of this study is to compare two different types of tablets of the drug named clonidine: a normal clonidine oral tablet and a mucoadhesive buccal tablet. The clonidine mucoadhesive buccal tablet (MBT) is a special type of tablet designed to stick to the gum, preventing it from being swallowed in order to keep the tablet in the mouth (where it is needed to work). The clonidine MBT is being developed to prevent severe oral mucositis caused by radiochemotherapy in patients with head and neck cancer.
Oral mucositis is a condition characterised by pain and inflammation affecting the soft layer of tissue on the inside of the mouth. Patients with head and neck cancer receiving radiotherapy with or without chemotherapy often develop oral mucositis, which remains one of the most common and troubling side effects of these treatments.
This study is designed to compare how the clonidine MBT tablets are absorbed into both the saliva and bloodstream compared to the standard oral tablet formulation of clonidine.
The study will be conducted in up to 36 subjects. The study will comprise of a screening visit (within 14 days of the first dose), followed by 3 Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose). Each Treatment Period will be of 6 days duration, from the afternoon before dosing (Day -1) until 96 hours (h) post-dose (morning of Day 5).
The population eligible to take part in the study are healthy male and female (nonpregnant/nonlactating with negative pregnancy test at the screening visit) subjects between 18 and 50 years of age.
REC name
Wales REC 2
REC reference
15/WA/0201
Date of REC Opinion
30 Jul 2015
REC opinion
Further Information Favourable Opinion