NCT00413426已完成1 期
An Open-labeled, Randomized, Single Dose, Three Period, 2-sequence Crossover Study to Investigate the Pharmacokinetics of Darifenacin When Given as 7.5 mg Oral Doses of a Modified Release Suspension, as Compared to the Commercial Modified Release Tablet in Healthy Adult
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Comparison of the PK of a single dose of 7.5 reference modified release tablet of darifenacin and the tested modified release liquid suspension (1.5 mg/ml) of darifenacin under fasted conditions in healthy subjects
研究概览
简要总结
This purpose of this study is to compare the how the body changes the blood level of a single dose of darifenacin when given as 7.5 mg modified release tablet and the modified release liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female subjects age 18 to 50 years of age (inclusive)
- •In good health
- •Female subjects either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
- •Body mass index within the range of 18.5 to 29.9 kg/m2 and weigh at least 45 kg
排除标准
- •History of
- •Urinary retention, narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon
- •Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (>2 days in a week), severe constipation, gastrointestinal obstructive disorders, and gastric retention.
- •Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats
- •Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
- •Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
- •Known hypersensitivity or severe adverse event to darifenacin or similar drugs
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study
- •Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result
- •Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •Drug or alcohol abuse within the 6 months prior to dosing
- •Use of prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
- •Participation in any clinical investigation within 4 weeks prior to dosing
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •Significant illness within 2 weeks prior to dosing.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Comparison of the PK of a single dose of 7.5 reference modified release tablet of darifenacin and the tested modified release liquid suspension (1.5 mg/ml) of darifenacin under fasted conditions in healthy subjects
Comparison of the PK of a single dose of darifenacin when given as an oral dose of a 7.5 mg modified release liquid suspension in the fed and fasted states
次要结局
- Safety and tolerability
研究者
研究点 (1)
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