Two-period crossover study to determine speed of raft formation assessed by scintigraphy in healthy volunteers.

• Conditions: To measure the formation and retention of alginate rafts in healthy volunteers; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-002341-35-GB
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-29
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Only subjects to whom all of the following conditions apply will be included:
1) Age: = 18 years, = 45 years
2) Sex: male
3) Those with a Body Mass Index of >20kg/m2, <27kg/m2.
4) Those who are willing to abstain from consuming alcohol from 48 hours prior to each dosing day.
5) Those who are willing to abstain from smoking tobacco whilst at the study centre.
6) Those who are willing to consume both the standard radiolabelled meal, which contains scrambled eggs and the radiolabelled study drug on each dosing day.
7) Subjects who have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects to whom any of the following conditions apply must be excluded:
1) Those previously randomised into the study.
2) Those who have suffered a >6kg unexplained weight loss in the previous 6 months.
3) Those who have a history of gastro-oesophageal reflux or active
gastrointestinal disease (particularly gastritis, gastroduodenal ulcer,
gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
4) Those who show evidence of clinically significant allergic, pulmonary,
neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine or haematological disease.
5) Those who are on a highly restricted salt diet.
6) Those with hypercalcaemia, nephrocalcinosis, recurrent calcium containing renal calculi, or phenylketonuria.
7) Those who have been hospitalised within the previous three months for major surgery or medical illness.
8) Those who have had a clinically significant illness within the previous four weeks.
9) Those who have taken any prescription or non-prescription medication within the previous seven days, prior to the screening visit, which the Principal Investigator considers would interfere with the study.
10) Those who have a history of drug hypersensitivity, which in the opinion of the Principal Investigator, might interfere with the study.
11) Those who have a current or recent (within one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances or solvents.
12) Those who consume abnormal quantities of coffee or tea according to the Principal Investigator’s judgement.
13) Those unable to communicate well with the Principal Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Investigator.
14) Those with difficulty in swallowing or chewing (e.g. those who have loose teeth, dentures, fillings, etc).
15) Those who are known to be hypersensitive or allergic to any of the active substances (e.g. sodium alginate, sodium bicarbonate, calcium carbonate) or any of the excipients
16) Those previously randomised into this study.
17) Those who have participated in a clinical trial in the previous 12 weeks or have taken part in a total of four or more studies in the past 12 months.
18) Those who participated in a study in which radioisotopes were administered or exposure to any radiation other than normal background radiation (e.g. X-rays, handling of radiolabelled materials) within the last 12 months.
19) Those unable in the opinion of the Investigator to comply fully with the study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified