Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation, With Fasting and Postprandial Administration, in Male and Female Healthy Volunteers, Produced by Biolab Sanus Farmacêutica Ltda
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Time to reach maximum (peak) plasma concentration following drug administration (tmax)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.
详细描述
This is a phase I study of zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and postprandial administration. Sample size is 28 volunteers, male and female, aged from 18 to 50 years old.
This is an open-label, randomized, crossover study. Each volunteer will be randomized to one of the following sequencies:
- Sequency 1: zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 2)
- Sequency 2: zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 2) Formulation will be administered in a single dose, orally in each period. The volunteers will be admitted in two different periods of 36 hours each, when investigational product will be administered and blood samples will be collected at pre-determined periods of time up to 24 hours for pharmacokinetics evaluation.
Primary objective is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 3.5 mg in healthy volunteers. As a secondary objective, it will be evaluated if there is any pharmacokinetics difference between genders.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers, aged from 18 to 50 years old (women cannot be pregnant or in breastfeeding period and should be committed to use an effective contraceptive method during the study)
- •Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 29.9 kg/m2
- •Good health conditions or without significant diseases, according to best medical judgment, according to medical history, blood pressure and heart rate measurements, pulse, temperature, physical examination, electrocardiogram (ECG) and complementary laboratory tests
- •Ability to understand the nature and objectives of the trial, including risks and adverse events, willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by informed consent form signature.
排除标准
- •Know hypersensitivity to the investigational product (Zolpidem) or chemically related compounds
- •History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism
- •Maintenance therapy with any drugs, except oral contraceptives
- •History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic, psychiatric, cardiologic or allergic diseases of any etiology , that requires pharmacological treatment or considered as clinically relevant by the investigator
- •Electrocardiographic findings that at investigator discretion are not recommended for study participation
- •Deviations on screening laboratory results that are considered as clinically relevant by the investigator
- •Intake of more than five cups of coffee or tea per day
- •History of abusive use of drugs and alcohol
- •Use of regular medication two weeks prior to study enrollment or use of any medications one week prior to study enrollment
- •Hospitalization for any reasons up to 8 weeks prior to start of first period of trial treatment
- •Treatment within 3 months prior to the start of trial treatment, with any drug with known and well-established toxic potential to major organs
- •Participation in any pharmacokinetics trial with more than 300 mL of blood draw or administration of any experimental drug within 12 months prior to trial treatment start
- •Donation or loss of 450 mL or more of blood within 3 months prior to trial enrollment or donation of more than 1500 mL of blood within 12 months prior to the trial treatment start
- •Positive result for the BHCG urine test, performed by female subjects
- •Positive results for the detection of abusive drugs at urine exam
- •Result higher than 0.1 mg/L for the etilometer exam
- •Any condition, according to investigator's best judgment, that prevents the subject to participate in the trial
研究组 & 干预措施
zolpidem hemitartarate (fasting + post-prandial)
zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial
干预措施: zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial) (Drug)
zolpidem hemitartarate (post-prandial + fasting)
zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting
干预措施: zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting) (Drug)
结局指标
主要结局
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
时间窗: 24 hours
Area under the curve (0-last)
时间窗: 24 hours
Maximum serum concentration (Cmax)
时间窗: 24 hours
Clearance (C)
时间窗: 24 hours
Area under the curve (0-inf)
时间窗: 24 hours
Half life (t1/2)
时间窗: 24 hours
Elimination rate constant (Ke)
时间窗: 24 hours
Volume of distribution (Vd)
时间窗: 24 hours
次要结局
- Intensity of adverse events(60 days)
- Number of adverse events(60 days)