NCT00913549已完成1 期
Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg 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
- 发起方
- Sandoz
- 入组人数
- 36
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
排除标准
- •Positive test results for HIV or hepatitis B or C.
- •Treatment for drug or alcohol dependence.
研究组 & 干预措施
1
Experimental
Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
干预措施: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories) (Drug)
2
Experimental
Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
干预措施: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 19 days
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Bioequivalency Study of Exemestane 25 mg Tablet Under Fed ConditionsBreast CancerNCT01331434Roxane Laboratories47
已完成
1 期
Bioequivalency Study of CM082 Tablet in Healthy VolunteersAdvanced Malignant Solid TumorsNCT04328506AnewPharma96
撤回
1 期
Pivotal Bioequivalence Study of Exemestane 25 mg Tablets Under Fasting Conditions in Healthy SubjectsHealthyNCT01760980Actavis Inc.
已完成
1 期
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-componentsHealthyNCT01276327Boehringer Ingelheim64
已完成
1 期
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage FormsOverweightNCT01550926GlaxoSmithKline48