Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 60
- 主要终点
- Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
研究概览
简要总结
Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
详细描述
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs.
In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal subjects who are 18-65 years of age.
- •Non-childbearing potential females or those using birth control.
排除标准
- •History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
- •History of significant gastrointestinal disease
- •Any significant medical illness
- •Gastrointestinal disorder or surgery leading to impaired drug absorption
- •Currently using gastrointestinal medications
研究组 & 干预措施
Zegerid
Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
干预措施: Omeprazole/sodium bicarbonate (Drug)
Prilosec
Omeprazole magnesium 20 mg OTC tablet
干预措施: omeprazole magnesium (20 mg equivalent) (Drug)
结局指标
主要结局
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
时间窗: Baseline and 7 days
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
次要结局
未报告次要终点