A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride (HCl) Prototype Capsule Formulations in Healthy Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Gastric Retention by Magnetic Resonance Imaging (MRI)
研究概览
简要总结
To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).
详细描述
This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods (total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2.
Subjects will be dosed in a sequential manner, as appropriate. Each subject will be administered up to 2 regimens (2 different prototype capsule formulations) across 2 study periods. There will be a minimum 35-day interval between each dose administration.
Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess the gastric retentive properties of the formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects.
- •Body mass index of 18.0 to 32.0 kg/m
- •Subjects must demonstrate their ability to swallow a test capsule at screening.
- •Must provide written informed consent.
排除标准
- •Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- •Subjects who have previously been enrolled in this study.
- •History of any drug or alcohol abuse in the past 2 years.
- •Current smokers and those who have smoked within the last 12 months.
- •Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- •Individuals with contraindication to MRI imaging.
- •Other protocol defined criteria may apply.
研究组 & 干预措施
Cohort 1
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days
干预措施: Memantine Hydrochloride MR Prototype Capsule Formulation A (Drug)
Cohort 1
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days
干预措施: Memantine Hydrochloride MR Prototype Capsule Formulation B (Drug)
Cohort 1
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation A; then formulation B; following each administration MRI will be performed for up to 14 days
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort 2
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation C; then formulation D; following each administration MRI will be performed for up to 14 days
干预措施: Memantine Hydrochloride MR Prototype Capsule Formulation C (Drug)
Cohort 2
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation C; then formulation D; following each administration MRI will be performed for up to 14 days
干预措施: Memantine Hydrochloride MR Prototype Capsule Formulation D (Drug)
Cohort 2
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation C; then formulation D; following each administration MRI will be performed for up to 14 days
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort 3
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days
干预措施: Memantine Hydrochloride MR Prototype Capsule Formulation E (Drug)
Cohort 3
Subjects will receive an oral administration of 50 mg of Memantine HCl prototype capsule formulation E; followed by MRI for up to 14 days
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Gastric Retention by Magnetic Resonance Imaging (MRI)
时间窗: 7 Days
Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing
次要结局
未报告次要终点