Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers
详细描述
This is a single-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study. Approximately, 24 healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence A group will receive imported mizolastine tablets and volunteers from Sequence B group will receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7 Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group will receive domestic mizolastine and volunteers from Sequence B group will receive imported mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be measured throughout the study. The maximum study duration for each volunteer will be approximately 16 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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No history of smoking
- •Body mass index between 18 and 28 kilogram per square meter
- •Health status considered good by the investigator according to physical examination, medical history, vital signs, electrocardiogram and clinical laboratory results
- •Must be able to read and understand the informed consent form and sign the informed consent form before carrying out any operation related to the study
排除标准
- •Health examination does not comply with the inclusion criteria
- •Serious alcohol abuse
- •Known allergy to active ingredients or excipients
- •Habitual use of any drug including Chinese medicine
研究组 & 干预措施
Sequence A
Healthy male volunteers will receive single oral dose of 10 mg imported mizolastine tablet on Day 1 and single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 8.
干预措施: Mizolastine domestic (made in China) (Drug)
Sequence A
Healthy male volunteers will receive single oral dose of 10 mg imported mizolastine tablet on Day 1 and single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 8.
干预措施: Mizolastine (imported) (Drug)
Sequence B
Healthy male volunteers will receive single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 1 and single oral dose of 10 mg imported mizolastine tablet on Day 8.
干预措施: Mizolastine domestic (made in China) (Drug)
Sequence B
Healthy male volunteers will receive single oral dose of 10 mg domestic (made in China) mizolastine tablet on Day 1 and single oral dose of 10 mg imported mizolastine tablet on Day 8.
干预措施: Mizolastine (imported) (Drug)
结局指标
主要结局
Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)
时间窗: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax)
时间窗: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
时间窗: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
时间窗: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
次要结局
- Number of volunteers with adverse events as a measure of safety and tolerability(Up to Day 16)