CTRI/2011/12/002292已完成不适用
A randomized, open-label, multiple dose, four-way cross-over pharmacodynamic equivalence study comparing orlistat 60 mg and 120 mg hard gelatin capsules [Orlistat (Laboratorios Liconsa S.A. vs alli® (Glaxo Group Limited) and Xenical® (Roche Registration Limited)] in healthy volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- PD Parameters
研究概览
简要总结
To investigate the pharmacodynamic equivalence of orlistat, using fat excreted in feces, from a new formulation of orlistat: Orlistat 60 mg hard gelatin capsules and Orlistat 120 mg hard gelatin capsules (Laboratorios Liconsa S.A, Spain) with the reference formulation alli® 60 mg hard capsules and Xenical® 120 mg hard capsules following multiple dose administration (three times a day) of each test and reference product to healthy subjects.
To evaluate the safety and tolerability of the formulations specified above
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Caucasian subjects, males or females ≥18 to ≤55 years old on the ." day of screening
- •If females: subjects who are willing to use tampon during menstruation
- •Informed Consent Form signed and dated prior to screening procedures.
- •BMI ≥25.00 to ≤30.00 kg/m2 (the minimum body weight for male subjects must be 70 kg, for female subjects.
- •Physical examination without any clinically relevant abnormality
- •No clinically relevant abnormal laboratory values (as per Annexure 2)
- •Subject who accepts the possible weight loss (approximately 10% change from the baseline)
- •Subjects who are willing to fast overnight each day and consume the repetitively provided standard meals during the whole study
- •Subject able and willing to understand and follow study related procedures.
排除标准
- •Known allergy or hypersensitivity to orlistat or its derivatives and/or to any study product excipients
- •Any known significant current or past acute or chronic disease or condition of the: circulatory system, respiratory system, hematopoietic system, alimentary tract, urinary tract, endocrine system, nervous system, musculoskeletal system, an allergic disease (excluding allergic rhinitis), genetic disorder or psychiatric disorder that could influence the present general health condition, at the Investigators discretion
- •Current disease of the alimentary tract, liver or kidneys that may influence absorption, distribution and/or elimination of the studied drugs, as assessed by the Investigator and documented in the medical history
- •Current disease of gall bladder and/or cholelithiasis
- •The malabsorption syndrome in medical history
- •Pancreatitis and/or nephrolithiasis in medical history
- •Constipation and/or diarrhea within 1 week before the screening
- •Participation in other clinical trials, where at least one dose of study drug was administered, within 30 days preceding the screening
- •Blood loss or donation exceeding 300 mL within 4 weeks preceding the screening
- •Blood pressure: systolic 140mmHg or 90mmHg, diastolic 60 mmHg or 90 mmHg at screening and on day O.
- •Body temperature: 36,0°C or 37,5°C on the day of screening and on Day O
- •Abnormal clinical laboratory results assessed by Investigator as clinically relevant (CR)
- •Positive results of HbsAg and/or anti-HCV and/or anti-HIV tests
- •Positive result of stool culture test against Salmonellal Shigella
- •Positive result of the stool ova, cysts & parasites (OCP) test
- •Clinically relevant abnormalities in ECG recording on the day of screening
- •Clinically relevant abnormalities in abdominal USG at screening
- •Current or ex-smoker or tobacco user who has stopped smoking less than six (6) months before screening
- •Pregnant, breast-feeding females
- •History of drug and/or alcohol dependence
- •Subjects who adhere to a special diet (e.g. vegetarian, protein, raw food, etc.) within 30 days preceding day 1 in run out period
- •of the Administration of drugs which may have an influence subjects condition or study results within 4 weeks preceding the first study drug administration.
- •Only the drugs in dose assessed by the Investigator as safe and not having an impact on the study results are allowed within this time (e.g. paracetamol, vitamins)
- •Ingestion of laxatives and/or fat-blocking nutritional supplements within 14 days preceding day 1 in run-in period
- •Alcohol consumption within 96 hours preceding day 1 in run-in period
- •Consumption of beverages containing caffeine or other methylxanthines (tea, coffee, cola, chocolate, cocoa, energy drinks) in excessive amount (Le. more than 1 liter daily) 29.
结局指标
主要结局
PD Parameters
时间窗: 24hour
The final results will be expressed as:
时间窗: 24hour
ingested fat (g) per each 24 h collection
时间窗: 24hour
excreted fat (g) per each 24 h sample
时间窗: 24hour
FFE24, F (Relative bioavailability), Daily ingested fat, Daily excreted fat, E0 (baseline), ED50, Emax
时间窗: 24hour
次要结局
- Data will be presented in individual listings and summary tables, and evaluated descriptively or by descriptive statistics((mean, SO, median, range) where appropriate.)
研究者
研究点 (3)
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