A Randomized, Single-dose, Two-way Crossover Study to Assess the Bioequivalence of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) Administered to Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval zero to infinity (AUC0-infinity)
研究概览
简要总结
Primary Objective:
To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg (Reference, R) following oral administration.
Secondary Objective:
To investigate the safety and tolerability of meloxicam following a single dose of meloxicam capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese subjects.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study
- •Healthy adult male, aged between 20 and 40 years old
- •Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram [kg]/height in meters2 [m2]).
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- •No significant deviation from biochemistry including: aspartate transaminase (SGOT/AST), alanine transaminase (SGPT/ALT), gamma-glutamyl-transferase (GGT), alkaline phosphatase, total bilirubin, albumin, glucose, blood urea nitrogen (BUN), creatinine, uric acid, total cholesterol and triglyceride.
- •No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
- •No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.
排除标准
- •History of drug or alcohol abuse within the past one year
- •Medical history of allergic asthma or sensitivity to analogous drug
- •Evidence of chronic or acute infectious diseases from 4 weeks before the study
- •Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
- •Ongoing peptic ulcer and constipation
- •Planned vaccination during the time course of the study.
- •Taking any clinical investigation drug from 3 months before the study
- •Use of any medication, including herb medicine or vitamins from 4 weeks before the study
- •Blood donation of more than 500 ml within the past 3 months
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
- •A positive test for HIV antibody
研究组 & 干预措施
Meloxicam capsule
Capsules 15 mg
干预措施: Meloxicam capsule (Drug)
Meloxicam tablet
Tablets 15 mg
干预措施: Meloxicam tablet (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval zero to infinity (AUC0-infinity)
时间窗: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Area under the plasma concentration-time curve from 0 h to last concentration time (AUC0-tz)
时间窗: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Observed maximum measured concentration of the analyte in plasma (Cmax)
时间窗: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Time to reach maximum plasma concentration (Tmax)
时间窗: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Plasma half-life estimated by (0.693/ kel) ( t ½)
时间窗: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
次要结局
- Drug induced changes in standard laboratory values(screening phase (at least 10hours fasting), before and 24 h following drug administration on each study day, within 14 days after completion of all two periods)
- Occurrence of adverse events(up to 33 days after first administration)