NCT01314339已完成1 期
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Healthy Subjects Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Bioavailability is based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting conditions.
详细描述
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Fasted Normal,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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is the individual a healthy, normal adult man and women who volunteers to participate?
- •Is s/he within 18 and 45 years of age, inclusive?
- •Is his/her BMI between 19 and 30, inclusive?
- •Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study?
- •Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
- •Has s/he provided written informed consent?
- •A no answer to any of the above questions indicates that the individual is ineligible for enrollment
排除标准
- •Does the individual have a history of allergy or hypersensitivity to desloratadine?
- •Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- •Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- •Is she nursing?
- •Does s/he have serious psychological illness?
- •Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
- •Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test?
- •Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? .
- •Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
- •Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
- •Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
- •Has s/he donated plasma during the two week period preceding study initiation?
- •Has s/he used any tobacco products in the 3 months preceding drug administration?
- •Has s/he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.
研究组 & 干预措施
Desloratadine Tablets, 5 mg
Experimental
Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories
干预措施: Desloratadine (Drug)
Clarinex
Active Comparator
Clarinex® 5 mg Tablets of Schering-Plough
干预措施: Desloratadine (Drug)
结局指标
主要结局
Bioavailability is based on Cmax and AUC parameters
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed ConditionsFedNCT01314352Dr. Reddy's Laboratories Limited28
已完成
1 期
Levetiracetam 1000 mg Under Fasting ConditionsHealthyNCT00859521Teva Pharmaceuticals USA30
已完成
1 期
Levetiracetam 1000 mg Under Non-Fasting ConditionsHealthyNCT00859430Teva Pharmaceuticals USA22
已完成
1 期
Buprenorphine 8 mg Sublingual Tablets Under Fasting ConditionsHealthyNCT01157169Teva Pharmaceuticals USA40
已完成
1 期
Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting ConditionsFastingNCT01506713Dr. Reddy's Laboratories Limited53