EUCTR2005-000974-29-GB进行中（未招募）1 期
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
Boots Healthcare International Limited0 个研究点目标入组 16 人开始时间: 2005年3月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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