A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
研究概览
简要总结
A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study
- •Subject is in good health
- •Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day
排除标准
- •Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
- •Subject has a history of asthma or severe allergies to drugs or foods
- •Subject currently uses prescribed or nonprescribed drugs on a regular basis
- •Subject has a recent history of drug/alcohol abuse
- •Subject consumes more than 6 cups of coffee per day
- •Subject has unconventional or extreme dietary habits
- •Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
- •Subject has a history of allergy or intolerance to antacids
- •Female subject is known to be pregnant or is not using reliable means of contraception
研究组 & 干预措施
A
Famotidine/antacid combination tablet with water
干预措施: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet (Drug)
结局指标
主要结局
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
时间窗: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
时间窗: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
次要结局
- Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water(Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose))
- Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water(Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose))