An Bioequivalence Study of Loxoprofen Sodium Patches in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Cmax of loxoprofen and its trans-OH
研究概览
简要总结
This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.
详细描述
The objectives of this study are to evaluate the difference of absorption degree and absorption rate of two kinds of patches( FB3002 vs. Loxonin®) in Chinese healthy population, and to assess the bioavailability of these two patches.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19.0 and 28.0 kg/m2, inclusive .
- •Informed consent: signed written informed consent before inclusion in the study.
- •The subjects are well communicated and are able to comply with the requirements of the study
排除标准
- •Participated in other drug intervention studies within 90 days
- •Allergic to this product and excipients, or have a history of food, drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.)
- •Aspirin asthma
- •Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial.
- •A history of cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, immune system, nervous/psychiatric system, blood and lymphatic system, and skeletal musculoskeletal system that investigator have determined to be abnormal and clinically significant
- •Postural hypotension, needle fainting or blood fainting history or venipuncture intolerance
- •Any drug that inhibits or induces liver metabolism has been used in the 30 days prior to screening. Inducers: barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole; Inhibitors: SSRI antidepressants, cimetidine, Diltiazem, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines
- •Blood donation or significant blood loss (>400 mL, except for female menstrual period) in the 3 months prior to screening, blood transfusion or use of blood products, or have a blood donation plan during/within 3 months after the study
- •Smoked more than 5 cigarettes per day in the 3 months prior to screening, or unwilling to prohibit the use of any tobacco products during the trial period
- •History of alcohol abuse within 6 months
- •Subjects who consumed excessive amounts of tea, coffee or caffeinated beverages within 3 months, or who did not agree to the prohibition of tea, coffee or caffeinated beverages in the study
- •Subjects who have special requirements for diet and cannot comply with a unified diet
- •History of drug abuse within 1 year
- •Subjects who have unprotected sex in 2 weeks, or planned to have a child during the study period, planned to donate sperm and eggs, or are unwilling to use one or more non-drug contraceptive methods during the study, or are unwilling to use contraception within 3 months after the study
- •Pregnant or nursing women
- •Positive skin scratch test positive
- •Clinically significant vital signs laboratory, physical examination, or 12-lead electrocardiogram abnormalities as judged by the investigator
- •Other situations that the investigator determines are not suitable for participating in this clinical trial
研究组 & 干预措施
Loxoprofen Sodium Patches (Sequence TR)
Dosage form: patch
Dosage: 100 mg/ patch
Frequency and duration: single dose
Subjects receive the test product (T) in the first period, then the reference product (R) in the second period.
干预措施: Loxoprofen Sodium Patches(reference product) (Drug)
Loxoprofen Sodium Patches (Sequence TR)
Dosage form: patch
Dosage: 100 mg/ patch
Frequency and duration: single dose
Subjects receive the test product (T) in the first period, then the reference product (R) in the second period.
干预措施: Loxoprofen Sodium Patches(test product ) (Drug)
Loxoprofen Sodium Patches (Sequence RT)
Dosage form: patch
Dosage: 100 mg/ patch
Frequency and duration: single dose
Subjects receive the reference product (R) in the first period, then the test product (T) in the second period
干预措施: Loxoprofen Sodium Patches(reference product) (Drug)
Loxoprofen Sodium Patches (Sequence RT)
Dosage form: patch
Dosage: 100 mg/ patch
Frequency and duration: single dose
Subjects receive the reference product (R) in the first period, then the test product (T) in the second period
干预措施: Loxoprofen Sodium Patches(test product ) (Drug)
结局指标
主要结局
Cmax of loxoprofen and its trans-OH
时间窗: 0-72 hours
Maximum plasma concentration. Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.
AUC0-T of loxoprofen and its trans-OH
时间窗: 0-72 hours
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t). Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.
AUC0-∞ of loxoprofen and its trans-OH
时间窗: 0-72 hours
Area under the plasma concentration curve from time 0 to ∞ (AUC0-∞). Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.
次要结局
- Adverse Events(0-14 days)
- Tmax of loxoprofen and its trans-OH(0-72 hours)
- t1/2 of loxoprofen and its trans-OH(0-72 hours)
- λz(0-72 hours)
- AUC_%Extrap(0-72 hours)
- Irritation score(0-14 days)