NCT03205605已完成早期 1 期
Determination of Serum Oxybutynin Levels After Using Oxybutynin Transdermal Delivery System and Transdermal Gel With and Without Standardized Heat Application in Healthy Human Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- PK Parameter
研究概览
简要总结
This research study is intended to determine the effect of heat and occlusion on oxybutynin products.
详细描述
This research study is intended to determine the effect of heat and occlusion on oxybutynin products. This study will use an oxybutynin patch and gel that have been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States; will not include any placebos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or non-pregnant, non-lactating women who are of any ethnic background between the age of 18 to 45 years old
- •Subjects must be non-smokers/tobacco users (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
- •Provide written informed consent before initiation of any of the study procedures
- •Agree not to participate in another clinical trial/study or to participate in an investigational drug study for at least one month after the last study session
- •Able to adhere to the study restrictions and protocol schedule
- •Able to participate in all study sessions
- •Subjects have upper arms large enough to allow for placement of 200 cm2 [31 in2] area for applications of gel. The arm distance from the greater tubercle to the olecranon process should be a minimum of 30 cm. The circumference of the upper arms should be a minimum of 30 cm.
- •Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
- •Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
- •Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
- •Have normal screening laboratories for urine protein and urine glucose
- •Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure day, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or a vasectomized partner
- •Agree not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day
- •Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
- •Have normal vital signs:
- •Temperature 35-37.9°C (95-100.3°F)
- •Systolic blood pressure 90-165 mmHg
- •Diastolic blood pressure 60-100 mmHg
- •Heart rate 55-100 beats per minute
- •Respiration rate 12-20 breaths per minute
排除标准
- •Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of any study session
- •Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
- •Participation in any ongoing investigational drug trial/study or clinical drug trial/study
- •History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
- •Active positive Hepatitis B, C and/or HIV serologies
- •Positive urine drug screening test
- •Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medication (e.g. bisphosphonates [to treat osteoporosis], anticholinergics [used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms], antihistamines, topical corticosteroids) and short term (<30 days) prescription medications during the period 0-3 days before a study session [vitamin, herbal supplements and birth control medications not included)]
- •Donation or loss of greater than one pint of blood within 60 days of entry to the study
- •Any prior allergies to oxybutynin, other ingredients in the patch, gel or oral tablet tested, to medical tape products or other skin patches
- •Subject has problems with urinary retention, gastric retention or gastrointestinal obstruction
- •Subject has ulcerative colitis
- •Subject has gastric reflux disease or esophagitis
- •Subject has uncontrolled narrow-angle glaucoma
- •Subject has myasthenia gravis
- •Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within one month before enrollment in this study or expects to receive an experimental agent during the study
- •Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
- •Consumption (food or drink) of alcohol within 24 h prior to dose administration
- •History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
- •History of diabetes
- •Hereditary skin disorders or any skin inflammatory conditions as reported by the volunteer or evident to the MAI
- •History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
- •Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arms), sunburn, raised moles and scars, open sores at application site (upper arms), scar tissue, tattoo, or coloration that would interfere with placement of products, skin assessment, or reactions to oxybutynin
- •BMI ≥30 kg/m2
研究组 & 干预措施
patch with heat
Other
patch
干预措施: oxybutynin (Drug)
baseline patch
Other
patch
干预措施: oxybutynin (Drug)
baseline gel
Other
gel
干预措施: oxybutynin (Drug)
gel with occlusion
Other
gel
干预措施: oxybutynin (Drug)
结局指标
主要结局
PK Parameter
时间窗: 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application
Cmax (N-desethyl oxybutynin)
次要结局
未报告次要终点
研究者
Audra Stinchcomb
Professor
University of Maryland, Baltimore
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Possible Effect of Oxytocin During Interaction Between Humans and AnimalsAnimal Assisted TherapyNCT01226017Norwegian University of Life Sciences18
招募中
不适用
Oxytocin Effects on Self Versus Other TouchHealthyNCT05899517University of Electronic Science and Technology of China40
已完成
4 期
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder ParticipantsUrinary Bladder, OveractiveNCT00613327Janssen Korea, Ltd., Korea345
已完成
3 期
Treatment of Hyperhidrosis With OxybutyninHyperhidrosisNCT01855256University Hospital, Brest62
尚未招募
3 期
To study the role of Oxybutinin in infants affected with posterior urethral valveCTRI/2023/08/056095Josy Thomas