An open label, oral bioavailability study to determine the levels of Amylmetacresol BP (AMC) and 2,4-dichlorobenzyl alcohol (DCBA) in the saliva of healthy volunteers after a single oral dose of Strepsils Original throat lozenge. - AMC and DCBA in Saliva

Phase 1

• Conditions: AMC and DCBA are indicated for the symptomatic relief of mouth and throat infections.

• Registration Number: EUCTR2005-000974-29-GB
• Lead Sponsor: Boots Healthcare International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Only volunteers to whom all of the following conditions apply will be included:
i)Age: Volunteers between 18 and 55 are eligible for inclusion;
ii)Sex: Both male and female volunteers are eligible for entry into the study;
iii)Status: Volunteers will be healthy volunteers;
iv)Volunteers 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Volunteers to whom any of the following conditions apply must be excluded:
i)Current upper respiratory tract infection (URTI), including colds, coughs, sore throat and influenza;
ii)History of URTI, including colds, coughs, sore throat and influenza, or history of an URTI in the previous 7 days;
iii)Current blocked nose, either due to an URTI or an allergy e.g. allergic rhinitis;
iv)Those who have or have had sinusitis in the previous 7 days;
v)Those with impaired salivary gland function, including Xerostomia.
vi)Those who present with any soft tissue abnormalities during the Oral Soft Tissue (OST) examination;
vii)Those who cannot produce sufficient saliva during the test collection at the screening visit (1ml in 1 minute);
viii)Those who are allergic to AMC/DCBA, or any other product excipients;
ix)Those who are allergic to aspirin;
x)Those who have hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency;
xi)Must not be taking any prescription medications, with the exception of oral contraceptives, HRT or thyroxine (at a dose which has been stabilised for at least 6 months), within the previous 7 days;
xii)Must not have taken any OTC medications within 24 hours of receiving the study medication;
xiii)Must not have taken any throat lozenges or pastilles, throat sweets, sore throat sprays or gums, including those with local anaesthetics, within 24 hours of receiving the study medication;
xiv)Those who have had anything to eat or drink (except water), or cleaned their teeth within 3 hours prior to the Test Visit;
xv)Those who have used a mouthwash/gargles within the previous 6 hours;
xvi)Those with a history of drug or alcohol abuse;
xvii)Current smokers
xviii)Women of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms, diaphragm, cap, FemidomÒ and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oopherectomy);
xix)Those previously enrolled into the study;
xx)Those unable in the opinion of the Study Investigator to comply fully with the study requirements;
xxi)Those who have participated in a clinical study in the previous 2 months.
xxii)Any volunteer holding North American citizenship as the BHI Clinical Trials Insurance does not cover those persons.

Study & Design

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