A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who give consent to voluntary participation by signing the informed consent form
- •Healthy adult males aged ≥19 and ≤45 years at screening
- •Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0
排除标准
- •Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
- •Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
- •Subjects who have participated in other clinical trial and received any other investigational products within 6 months before the expected date of IP administration
- •Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
- •Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
- •Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
- •Smokers who have smoked >10 cigarettes per day within the last 6 months
- •Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and (venereal disease research laboratory) VDRL tests
研究组 & 干预措施
Sequence A (RT)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
• Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal.
干预措施: Rebamipide SR 150mg after high-fat meal (Drug)
Sequence A (RT)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
• Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal.
干预措施: Rebamipide SR 150mg under fasting condition (Drug)
Sequence B (TR)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
• Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal.
干预措施: Rebamipide SR 150mg after high-fat meal (Drug)
Sequence B (TR)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
• Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal.
干预措施: Rebamipide SR 150mg under fasting condition (Drug)
结局指标
主要结局
Cmax
时间窗: From Period1/ Day1 to Period2/Day9
Peak Plasma Concentration of Rebamipide
AUClast of Rebamipide
时间窗: From Period1/ Day1 to Period2/Day9
Area Under the plasma concentration versus time curve last of Rebamipide
次要结局
- AUCinf of Rebamipide(From Period1/ Day1 to Period2/Day9)
- t1/2 β of Rebamipide(From Period1/ Day1 to Period2/Day9)
- Tmax of Rebamipide(From Period1/ Day1 to Period2/Day9)