TCTR20210519007尚未招募1 期
Bioequivalence Study of Topical 0.1% Mometasone Furoate Cream in Healthy Thai Volunteers
International Bio Service0 个研究点目标入组 68 人开始时间: 2021年5月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination including vital signs measurement, 12-lead ECG and clinical laboratory tests.)
- •2. Body Mass Index between 18.0 to 25.0 kg/m2.
- •3. Have voluntarily given written informed consent (signed and dated) by the subject to participate in this study.
- •4. Willing to follow study restrictions and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •5. Subjects have skin type III, IV, V, VI as categorized by Fitzpatrick Skin Type (13-16). (See how to evaluate the Fitzpatrick skin type in the section below.)
- •6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during screening. Some of the laboratory values e.g. complete blood count etc that is out of the normal or reference range will be carefully considered by the clinical investigator.
- •7. Subjects demonstrate adequate vasoconstriction to topical corticosteroids as -good responder- (See details in the section below and in the Section IV (E) in the Guidance of Topical Dermatologic Corticosteroid: In Vivo Bioequivalence, 2 June 1995.)
排除标准
- •1. History of hypersensitivity or adverse reaction to systemic corticosteroids or topical mometasone furoate cream/cream or or any of the excipients of this product.
- •2. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- •3. Clinically significant hypertension or circulatory diseases.
- •4. Individuals smoking within one week of study.
- •5. Caffeine intake greater than 500 mg per day prior to or during the study. (A cup of coffee contains about 85 mg of caffeine.)
- •6. Clinically significant history of alcoholism or drug abuse.
- •7. Use of topical dermatologic drug therapy on ventral forearms, including prior dosing of a topical corticosteroid in a pharmacodynamic study to a particular skin site, within one month prior to the study.
- •8. Persons who have history of allergy or side effect from methylhydroxybenzoate, Imidurea, and propyl hydroxybenzoate.
- •9. Any current or past medical conditions, including active dermatitis or any other dermatologic conditions, which might significantly affect pharmacodynamic response to the administered drug.
- •10. Persons who would require shaving ventral forearms to insure consistent dose on skin surface.
- •11. Use of any vasoactive (constrictor or dilator) medication, prescription or OTC, that could modulate blood flow. Examples of such drugs include nitroglycerin, antihypertensives, antihistamines, NSAID, aspirin, and OTC cough/cold products containing antihistamines and/or either phenylpropanolamine or phentolamine.
- •12. Any obvious difference in skin color between arms.
- •13. Persons who have livedo racemosa.
- •14. Females who are pregnant.
研究者
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