跳至主要内容
临床试验/NCT00947024
NCT00947024已完成1 期

The Effect of Food on the Bioavailability of Glipizide

Sandoz0 个研究点目标入组 18 人开始时间: 1993年11月最近更新:
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
18
主要终点
Bioequivalence based on AUC and Cmax

研究概览

简要总结

To demonstrate the effect of food on the bioavailability of Glipizide.

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

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

3

Active Comparator

10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.

干预措施: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast. (Drug)

1

Experimental

10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.

干预措施: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast. (Drug)

2

Experimental

10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.

干预措施: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast. (Drug)

结局指标

主要结局

Bioequivalence based on AUC and Cmax

时间窗: 15 days

次要结局

未报告次要终点

研究者

发起方
Sandoz
申办方类型
Industry

相似试验

To Demonstrate the Effect of Food on the... | 临床试验