NCT00865605已完成1 期
A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Pivotal Bioequivalence Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Primary outcome: Vasoconstrictor Response
研究概览
简要总结
The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).
详细描述
Study Type: Interventional Study Design: A single blind, single-exposure study on healthy adult male and female subjects.
Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Pivotal Bioequivalence Study
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Vasoconstrictor Response
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject understands the study, is willing to participate, and gives written informed consent.
- •Subject demonstrates adequate vasoconstriction to the screening topical corticosteroid Halobetasol propionate 0.05% ointment within 30 days of dosing.
- •Subject is a non-smoking (minimum of 14 days), male or female, ages of 18 - 65 years, inclusive.
- •Subject is within 20% of their ideal body weight as defined by the 1999 Metropolitan Life Insurance Company Height and Weight Tables.
- •Subject is judged by the Investigator to be healthy on the basis of pre-study medical history.
- •Subjects of child-bearing potential agree to use an acceptable method of birth control during study participation (e.g. abstinence, any prescribed birth control method, double barrier method, Le. condom plus foam, condom plus diaphragm).
- •Subject is willing to refrain from excessive consumption of sodium in food or beverage 48hrs before and for the duration of the study.
- •Subject is willing to shower using the same soap/cleansers for the duration of the study.
- •Subject is willing to follow study restrictions.
排除标准
- •Subject has a past or current medical condition that might significantly affect pharmacodynamic response to topical corticosteroids.
- •Subject has diabetes mellitus, clinically significant hypertension or circulatory disease.
- •Subject is taking any medication on a regular basis that could modulate blood flow (constrictor or dilator), with the exception of any prescribed birth control method and hormone replacement therapy. Examples of such drugs include nitroglycerin, anti- hypertensives, antihistamines, NSAIDs, aspirin, phenylpropanolamine, phentolamine or any other medications deemed inappropriate by the Investigator.
- •Subject is planning to use any exclusionary over-the-counter (OTC) medications within 48 hours prior to or throughout the study that could modulate vascular blood flow.
- •Subject intends to start, stop or change dose of any prescription or OTC medication within 48 hours prior to or throughout the study. Acetaminophen may be administered, if needed.
- •Subject has used prescription or OTC topical medications on the ventral forearms within 1 month prior to study conduct.
- •Subject has a history of sensitivity/allergy to the ingredients found in the test formulations or has a history of adverse reactions to topical or systemic corticosteroids.
- •Subject has a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
- •Subject has a history of significant skin conditions or disorders, for example, psoriasis, atopic dermatitis, etc.
- •Subject has a history of significant dermatologic cancers, for example, melanoma or squamous cell carcinoma. Basal cell carcinomas that were superficial and do not involve the investigative site are acceptable.
- •Subject has an obvious difference in skin color between arms or the presence of a skin condition, scar tissue, tattoo or coloration that would interfere with placement of test sites, their assessments, their reaction to drug or could compromise the safety of the subject.
- •Subject has used topical medications on the ventral forearms within 1 month prior to dosing.
- •Subject has used a tobacco product within 14 days of study conduct.
- •Subject has a clinically significant history of drug abuse or alcoholism.
- •Subject has donated or received blood within 30 days prior to dosing.
- •Subject's caffeine intake is greater than 500 mg per day (1 cup of coffee contains approximately 85 mg of caffeine).
- •Subject is unwilling to abstain from alcohol or caffeine for 48 hours prior to and throughout the study.
- •(Females only): Subject is pregnant or lactating.
- •Subject has participated in another investigational drug, medical device, or biologics study within 30 days prior to dosing.
研究组 & 干预措施
A
Experimental
Halobetasol Propionate 0.05% Ointment, single exposure
干预措施: Halobetasol Propionate 0.05% Ointment, single exposure (Drug)
B
Active Comparator
Ultravate® 0.05% ointment, single exposure
干预措施: Ultravate® 0.05% ointment, single exposure (Drug)
结局指标
主要结局
Primary outcome: Vasoconstrictor Response
时间窗: 36 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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