NCT02260063已完成1 期
A Trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, Compared to the Reference Product Tablets
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
- 24
- 主要终点
- Area under the curve (AUC) of plasma concentration (CP)
研究概览
简要总结
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets
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
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female, non-smoker and non-alcohol user, healthy volunteers, of 21 - 45 years of age. To be eligible, women must not be pregnant or lactating and they must not be taking hormone contraceptives
- •Volunteers must not have a history of liver or renal disease or a history of psychiatric disorder. Volunteers will be submitted to the biochemical tests listed below, the results of which must be within expected normal values: complete blood count, erythro-sedimentation rate, GOT (glutamate oxalacetate transaminase) GPT (glutamate pyruvate transaminase), blood creatinine, glycemia, uremia, blood cholesterol, pregnancy test. HIV test (with prior written consent), serum tests for Chagas disease, hepatic b and syphilis, complete urinalysis, ECG (electrocardiogram) and chest x-ray
- •Volunteers must have discontinued all pharmacological treatment at least two weeks before entering this trial
- •informed written consent, signed prior to the start of this trial
排除标准
- •Volunteers requiring any kind of pharmacological treatment or having some known addiction
- •Volunteers having participated in any other clinical trial during the four preceding weeks
- •Volunteers who must start a treatment incompatible with this trial during its course
- •Volunteers who do not comply with the fasting requirements established in the trial or who do not comply with trial requirements such as avoiding intake of coffee, tea, cola soft drinks, etc. for 24 hours prior to the start of the trial
- •History of allergy or intolerance to Epinastine
- •Uncooperative volunteers
- •Previous participation in this trial
研究组 & 干预措施
Epinastine syrup
Experimental
干预措施: Epinastine syrup (Drug)
Epinastine tablets
Active Comparator
干预措施: Epinastine tablets (Drug)
结局指标
主要结局
Area under the curve (AUC) of plasma concentration (CP)
时间窗: Up to 24 hours after drug administration
Absorption rate Cpmax/AUC
时间窗: Up to 24 hours after drug administration
次要结局
- Number of participants with adverse events(Up to 24 hours after last drug administration)
- Number of participants with abnormal findings in physical examination(Up to 24 hours after last drug administration)
- Time to peak (Tmax)(Up to 24 hours after drug administration)
- Peak plasma concentration (Cpmax)(Up to 24 hours after drug administration)
- Drug half - life (T1/2)(Up to 24 hours after drug administration)
- Number of participants withdrawn or discontinued due to safety reasons(Up to 24 hours after last drug administration)
- Number of participants with clinically significant findings in vital signs(Up to 24 hours after last drug administration)
研究者
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