NCT00946725已完成1 期
A Comparative Bioavailability Study of Atenolol Tablets, 100 mg
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
- 28
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioavailability of atenolol tablets, 100 mg.
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 50 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
Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
干预措施: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.) (Drug)
2
Active Comparator
Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
干预措施: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 20 days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
To Demonstrate the Relative Bioavailability of Atenolol TabletsHypertensionNCT00913965Sandoz24
已完成
1 期
Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting ConditionsHigh Blood PressureMigraine HeadachesChest PainNCT00960245Sandoz34
已完成
不适用
Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices.Cocoa and chocolate products have generated significant interest due to their association with various health-protective and therapeutic activities. Cocoa and chocolate are rich sources of flavan-3-ols, which are present in monomeric and polymeric forms.NL-OMON22741ProDigest BVBATechnologiepark 3, 9052 Zwijnaarde, BelgiëTel: +32/ 9 264 59 786
尚未招募
不适用
Bioavailability of phenolics from olive leaf extract.pharmacokinetics of oleuropein metabolitesNL-OMON21153BioActor BV16
已完成
1 期
A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting ConditionsHealthyNCT00834366Labopharm Inc.26