NCT01506050已完成1 期
Randomized, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet 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
- 35
- 试验地点
- 1
- 主要终点
- Area under curve(AUC)
研究概览
简要总结
This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.
详细描述
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5 mg), desloratadine ODT 5 mg under fasting conditions. The treatment phases were separated by a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 35 of these enrolled subjects completed the study.
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 or woman who volunteers to participate?
- •Is s/he within 18 to 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 week 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?
排除标准
- •Does the individual have a history or 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 disease 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-I, 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 received an investigational drug during the 30 day period preceding study initiated?
- •Has s/he used any tobacco products in the 3 months preceding drug administration?
研究组 & 干预措施
Desloratadine OD tablets 5 mg
Experimental
Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited
干预措施: Desloratadine (Drug)
Clarinex
Active Comparator
Clarinex 5 mg of Schering Corporation Inc USA
干预措施: Desloratadine (Drug)
结局指标
主要结局
Area under curve(AUC)
时间窗: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120 and 144 hours post-dose
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
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed ConditionHealthyNCT01506037Dr. Reddy's Laboratories Limited36
已完成
1 期
Bioequivalence Study of Daclatasvir From Prodactariv 60 mg Film Coated Tablets (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)HealthyNCT02780362Genuine Research Center, Egypt24
已完成
1 期
Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)HealthyNCT02816970Genuine Research Center, Egypt24
已完成
1 期
Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)HealthyNCT02675127Genuine Research Center, Egypt24
已完成
1 期
Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)HealthyNCT02756936Genuine Research Center, Egypt24