EUCTR2008-000844-15-PL进行中（未招募）1 期
A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%
Pfizer Inc. 235 East 42nd Street, NEW YORK, NY 10017. US0 个研究点目标入组 30 人开始时间: 2008年7月3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
- 30
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
- 性别
- All
入选标准
- •male or female subjects of any age with glaucoma or ocular hypertension, receiving treatment with latanoprost 0.005% in one or both eyes for a minimum of 2 weeks.
- •evidence of signed and dated an informed consent document indicating that the subject or the subject’s parent (or legal guardian) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws and regulations.
- •willing and able to comply with schedule visits, treatment plan, and other study procedures (subject and for minors, parent/legal guardian).
- •females of childbearing potential (post menarchal females) must have a negative urine pregnancy test at screening or on the study day (prior to dosing).
- •Are the trial subjects under 18? yes
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit.
- •history of ocular trauma or surgery in either eye within 3 months of the screen visit.
- •history of hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients contained in Xalatan.
- •use of continuous wear contact lenses.
- •pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the dose of study medication until 28 days after dosing.
- •evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •history of febrile illness within 5 days prior to the start of the study.
- •other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •treatment with an investigational drug within 30 days or 5 half-lives preceding the first day of study.
- •history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
研究者
相似试验
已完成
不适用
An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects with Advanced Malignancies and Varying Degrees of Hepatic ImpairmentNL-OMON41294Onyx Therapeutics, Inc.5
尚未招募
不适用
A5375-A169 Respiratory tuberculosis unspecified, without mention of bacteriological or histological confirmation-B24 Unspecified human immunodeficiency virus [HIV] diseaseRespiratory tuberculosis unspecified, without mention of bacteriological or histological confirmationUnspecified human immunodeficiency virus [HIV] diseaseA169B24PER-024-19INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
已完成
1 期
Pharmacokinetics of Miist Nicotine Inhaler in healthy smokersSmoking cessationMental Health - AddictionACTRN12623001317684Miist Therapeutics South Pty Ltd10
已完成
1 期
A mass-balance study of [14C]KDT-3594 in healthy adult maleHealthy conditionJPRN-jRCT2071220057Shimizu Yoshitaka8
进行中（未招募）
1 期
A Study to Investigate the Pharmacokinetics (PK) and Safety of Risdiplam in Infants with Spinal Muscular AtrophySpinal Muscular Atrophy (SMA)MedDRA version: 20.1Level: LLTClassification code: 10041583Term: Spinal muscular atrophy unspecified Class: 10010331MedDRA version: 20.1Level: PTClassification code: 10041582Term: Spinal muscular atrophy Class: 100000004850MedDRA version: 20.1Level: LLTClassification code: 10051203Term: Spinal muscular atrophy congenital Class: 10010331CTIS2023-505602-42-00F. Hoffmann-La Roche AG10