A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity
研究概览
简要总结
The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.
详细描述
Subjects were required to observe a ten-hour fast and a one-hour fluid restriction prior to each dosing period.
Subjects were randomized into one of two active treatment groups, received supervised dosing of their treatment with approximately eight ounces of water, and were required to maintain fluid restriction for one hour after treatment. Following the one-hour post-dose fluid restriction, subjects could drink water, but consumer no other food or fluids for four hours post-dose.
Following a seven-day washout period, the comparison treatment was administered according to the same procedure as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 male and/or female subjects between the ages of 18 and 55 years, inclusive
- •approximately 18 to 30 kg/m2 BMI
- •total body weight at least 55 kg (121 lbs)
- •able to understand and sign the written Informed Consent Form
- •willing to follow the protocol requirements and comply with protocol restrictions
排除标准
- •pregnant or lactating women
- •women of childbearing potential not using acceptable form of contraception 3 months prior to the first dose until completion of follow-up procedures
- •history of allergy, sensitivity, and/or idiosyncratic reaction to Benadryl, diphenhydramine hydrochloride, or diphenhydramine citrate
- •evidence of clinical, dietary or psychiatric deviation from normal that could increase the risk to the subject or research staff or interfere with the interpretation of study results
- •use of licit or illicit drugs
- •participated in any other trials within a specified number of days prior to the first dose of the trial treatment
研究组 & 干预措施
1
Diphenydramine HCl
干预措施: Diphenhydramine hydrochloride (Drug)
结局指标
主要结局
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUC0-t and AUC0-infinity
时间窗: At 15 minutes pre-dose (0 hour), and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 36 and 48 hours post-dose
次要结局
- The safety analysis included all subjects who took at least one dose of clinical trial test product and had any follow-up information. Subjects in the safety analysis set were summarized and listed, based on actual treatment received.(15 minutes pre-dose (0 hour) through 28 days post-dose)