ACTRN12616000648426已完成1 期
Bioequivalence study of a generic formulation of cysteamine bitartrate (Rec 0/0462, 150 mg immediate release capsules) versus the marketed Cystagon Registered Trademark, 150 mg immediate release capsules, in healthy volunteers administered a single 600 mg doseSingle centre, single dose, randomised, open, two way, two period, cross-over, two stage bioequivalence study
CROSS SA (this is the full name of the primary sponsor)0 个研究点目标入组 24 人开始时间: 2016年5月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1 Informed consent: signed written informed consent before inclusion in the study
- •2.Sex and Age: males/females of 18-45 year old inclusive
- •3.Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- •4.Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, heart rate (HR) 50-90 beats/min, measured after 5 min at rest in the sitting position
- •5.Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- •6.Lifestyle: non-smokers or ex-smokers for at least 2 years
- •7.Contraception and fertility (females only): females of childbearing potential had to accept using a double reliable contraceptive method (one mechanical barrier method plus another one).
排除标准
- •1. 12 leads ECG (supine position): clinically significant (CS) abnormalities or:
- •a. PQ interval < 120 msec or > 220 msec
- •b. QRS duration < 75 msec or > 120 msec
- •c. QTcB manual value > 440 msec (QTcB was measured manually only if QTcB > 440 msec)
- •2.Physical findings: CS abnormal physical findings which could interfere with the objectives of the study
- •3.Laboratory analyses: CS abnormal laboratory values indicative of physical illness
- •4.Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients and to penicillamine; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered may affect the outcome of the study
- •5.Diseases: significant history of renal, hepatic, gastrointestinal (in particular gastrointestinal bleeding or chronic gastrointestinal disease), cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
- •6.Medications: medications, including over the counter (OTC) medications and herbal remedies, for 2 weeks before the start of the study, in particular current HIV or hepatitis treatment in the last three months. Hormonal contraceptives for females were allowed
- •7.Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that followed the last visit of the previous study and the first day of the present study
- •8.Blood donation: blood donations for 3 months before this study
- •9.Drug, alcohol, caffeine: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010] or caffeine (>5 cups coffee/tea/day) abuse
- •10.Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •11.Drug test: positive drug test at screening or Day -1
- •12.Alcohol test: positive alcohol breath test at Day -1
- •13.Pregnancy: pregnant or lactating women
- •14.Pregnancy test (all female subjects): positive pregnancy test at screening or Day -1
研究者
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