NCT01133470已完成1 期
An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, 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
- 54
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to
- Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.
- Monitor the adverse events and ensure the safety of subjects.
详细描述
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc., USA in healthy, adult, human subjects under fasting conditions.
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
- •Human subjects aged between 18 and 45 years (including both)
- •Subjects'weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9kgm2)with minimum of 50 kg weight.
- •Subjects with normal health as determined by personal medical history clinical examination and laboratory examinations within the clinically acceptable normal range.
- •Subjects having normal 12-lead electrocardiogram (ECG).
- •Subjects having normal chest X-Ray (P/A view).
- •Have a negative urine screen for drugs of abuse (including amphetamines,barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Have negative alcohol breath test.
- •Subjects willing to adhere to the protocol requirements and to provide written informed consent.
排除标准
- •Subjects will be excluded from the study, if they meet any of the following criteria:
- •Hypersensitivity to Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride or related drugs.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
- •History or presence of significant asthma, urticaria or other allergic reactions.
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
- •Diastolic blood pressure less than SO mm Hg or more than 90 mm Hg.
- •Pulse rate less than 50/minute or more than 100/minute.
- •Oral temperature less than 95°F or more than 98.5°F.
- •Respiratory rate less than 12/minute or more than 20/minute
- •SUbjects who have used any prescription medication, within 14 days of period 01 dosing or OTC medication within 14 days of period 01 dosing.
- •Major illness during 3 months before screening.
- •Participation in a drug research study within past 3 months.
- •Donation of blood in the past 3 months before screening.
- •Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to period 01 dosing.
- •Subjects who have consumed food or beverages containing grapefruit or pomelo within 14 days prior to period 01 dosing.
研究组 & 干预措施
Fexofenadine HCl + Pseudoephedrine HCl
Experimental
Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories
干预措施: Fexofenadine HCl + Pseudoephedrine HCl (Drug)
Allegra-D 24 hour ER Tablets
Active Comparator
Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA.
干预措施: Fexofenadine HCl + Pseudoephedrine HCl (Drug)
结局指标
主要结局
Bioequivalence 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)
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