Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 27 人开始时间: 2008年4月10日最近更新: 2018年8月31日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 27
试验地点: 1
主要终点: Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy Japanese adult males between 20 and 55 years of age, inclusive.
•Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.
•Bodyweight >50 kg and body mass index (BMI) between 18.5 and 28.0 at screening.
•Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•Baseline QTc interval <450 msec.
•Non-smoker or ex-smoker having ceased smoking for at least 6 months.
•Clinical laboratory examination (AST, ALT, ALP and GGT) at screening are within the normal range.
•The subject is able to attend all visits and complete the study.

排除标准

•Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
•History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
•Positive for urine drug at screening.
•Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.
•Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.
•History of drug abuse, or current conditions of drug abuse or alcoholism.
•Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first application of study medication.
•Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
•History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
•The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
•At the part obtaining keratinized layer, having exanthem, pigment abnormality, the skin symptoms such as wounds and/or an excessive sunburn.
•History of clinically significant itching, erythema and/or rash by any paster.