NCT01179659已完成1 期
A Pharmacokinetic Study to Assess the Bioequivalence of a Single-Dose of KUDCO and Wyeth Pharmaceuticals (Protonix) 40 mg Pantoprazole Sodium Delayed-Release Tablet When Administered to Healthy Adult Volunteers Under Fed Conditions
Kremers Urban Development Company1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2005年9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
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cmax (maximum observed concentration of drug substance in plasma)
研究概览
简要总结
The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.
详细描述
This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence study under fed 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
- •Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- •Medically healthy subjects with clinically normal laboratory profiles, vital signs, and ECG.
- •Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study, or using one of the following acceptable birth control methods:
- •Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- •Intrauterine device (IUD) in place for at least 3 months.
- •Barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
- •Surgical sterilization of the partner (vasectomy for 6 months minimum).
- •Hormonal contraceptives for at least 3 months prior to the first dose of the study.
- •Gave voluntary written informed consent to participate in the study.
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- •In addition, history or presence of:
- •Alcoholism or drug abuse within the past 2 years;
- •Hypersensitivity or idiosyncratic reaction to pantoprazole, omeprazole, or any other substituted benzimidazole proton-pump. inhibitors.
- •Females who were pregnant or lactating.
- •History of tobacco use or use of products containing nicotine (i.e., smoking cessation aids such as nicotine gum or patches) within the 6 months prior to the first dose.
- •Subjects who tested positive at screening for human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen screen (HbsAg), or hepatitis C antibody screen (HCV).
- •Treatment with any known enzyme-altering drugs (barbiturates, phenothiazines, cimetidine, etc.) within 30 days prior to the first dose.
- •Difficulty in swallowing medication or any gastrointestinal disease that would affect the drug absorption.
- •Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- •Subjects who, through completion of the study, would have donated in excess of:
- •500 mL of blood in 14 days;
- •1500 mL of blood in 180 days;
- •2500 mL of blood in one years.
- •Subjects who participated in another clinical trial with 28 days prior to the first dose.
研究组 & 干预措施
Protonix
Active Comparator
Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
干预措施: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet (Drug)
Pantoprazole 40 mg DR Tablet
Experimental
Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
干预措施: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet (Drug)
结局指标
主要结局
Cmax (maximum observed concentration of drug substance in plasma)
时间窗: 26 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
时间窗: 26 hours
AUC0-inf (area under the concentration-time curve from time zero to infinity)
时间窗: 26 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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