NCT00358371已完成1 期
A Mono-center, Open, Randomized, Three-way, Twelve-sequence, Cross-over Study to Determine the Extent of Absorption (Absolute Bioavailability), Rate of Absorption and to Further Characterize Distribution and Elimination Characteristics of a Commercial 250 mg and a 500 mg Capsule of Flucloxacillin Each Given as a Single Oral Dose vs. One 250 or 500 mg Intravenous Dose to 24 Healthy Male and/or Female Subjects in the Fasting State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Absolute (Abs.) bioavailability, max. plasma conc., concentration-time curve (AUC) from 0 hto the last quantifiable conc., AUC from 0 h to infinity), timepoint of max. plasma conc., Halflife of drug elimination during the terminal phase
研究概览
简要总结
Primary objective:To study the absolute bioavailability, distribution and elimination parameters of flucloxacillin from two oral formulations of flucloxacillin in healthy male and/or female subjects.
详细描述
A mono-center, open, randomized, three-way, twelve-sequence, cross-over study to determine the extent of absorption (absolute bioavailability), rate of absorption and to further characterize distribution and elimination characteristics of a commercial 250 mg and a 500 mg capsule of flucloxacillin each given as a single oral dose vs. one 250 or 500 mg intravenous dose to 24 healthy male and/or female subjects in the fasting state
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers,
- •Caucasians,
- •Body Mass Index (BMI) between 19 and 27 kg/m 2;
- •physically and mentally healthy as judged by means of a medical and standard lab examination;
- •non-smokers,
- •ex-smokers or moderate smoker.
- •Exclusion criteria:
- •medical history,
- •vital signs,
- •physical examination,laboratory tests (blood and/or urine) with evidence of clinically significant conditions;
- •12-lead electrocardiogram (ECG) with clinically significant abnormality;acute infection within 2 weeks preceding 1st study drug administration;any medication on a regular basis (exception females: oral contraceptives) and/or tricyclic antidepressants, antacids, histamine H2-receptor antagonists, antibiotics,
- •non steroid anti-inflammatory drugs or anticoagulants within 8 weeks before the 1st study drug administration and/or no agreement to take any of those drugs including Over-the-counter (OTC) drugs until the end of the follow- up examination;
- •no agreement not to take any medication,including OTC medicine, antacids, or analgesics within 2 weeks before 1st drug administration until the end of the follow-up examination;special diet or loss of > 5 kg within last month from a weight reduction diet; regularly consume of large quantities of alcohol (> 20g/day) and/or beverages containing methylxanthines e.g. caffeine (> 0.5L/day altogether);
- •no agreement not to consume: - any beverages or foods containing alcohol 48 h prior to 1st study drug administration until end of the follow-up examination;
- •any grapefruit products 7 days prior 1st study drug administration until end of the follow-up examination,
- •any beverages or foods containing methylxanthines as well as fruit-juices and any foods containing poppy seed 48 h before 1st drug administration of either study period until last blood sample of the respective study period was collected,
- •not to consume chewing during confinement;
- •history of: - allergy to flucloxacillin,
- •B-lactams and/or related drugs,
- •known hypersensitivity against the inactive ingredients of the study medication,
- •hypersensitivity to multiple drugs,
- •allergic diseases,
- •acute hay fever,
- •previous history of flucloxacillin-associated jaundice/hepatic dysfunction,
- •alcohol or drug abuse,
- •epilepsy or other seizure,
- •psychiatric illness, e.g. latent or manifest depression schizophrenia, or neurosis,
- •respiratory diseases,
- •surgery of the gastrointestinal tract (except appendectomy),
- •kidney diseases,
- •bleeding/coagulation disorder or severe anaemia,
- •glucose-6-phosphate dehydrogenase deficiency and/or chronic treatment or chronic pathology;
- •metabolic disease;
- •evidence for disorder in the metabolism of pharmaceuticals or other foreign compounds; cardiovascular diseases e.g. hypertension, hypotension or bradycardia;
- •associated disease that would interfere with the clinical course of the trial;
- •major illness during 3 month before commencement of the screening period,
- •gastrointestinal diseases;
- •reported or positive results from test of drugs of abuse (amphetamines, opiates, barbiturate, methadone, cannabinoids, cocaine, benzodiazepines);
- •Positive test for: alcohol, Hepatitis-B-antigen or Hepatitis-C-antibody, HIV-antibody;blood donor or blood loss including plasmapheresis within the last 3 months before the 1st study drug administration;
- •intake of depot injectable solutions (including study medication) within 6 month before 1st study administration;
- •intake of enzyme-inducing and/or organotoxic drugs within 4 weeks before 1st study drug administration;for females only: positive results from pregnancy tests;does not use or not agree to use adequate contraceptive methods during the study;
- •lactating woman.
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving flucloxacillin 250 mg
Experimental
Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
干预措施: flucloxacillin 250 mg (Drug)
Subjects receiving flucloxacillin 500 mg
Experimental
Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
干预措施: flucloxacillin 500 mg (Drug)
结局指标
主要结局
Absolute (Abs.) bioavailability, max. plasma conc., concentration-time curve (AUC) from 0 hto the last quantifiable conc., AUC from 0 h to infinity), timepoint of max. plasma conc., Halflife of drug elimination during the terminal phase
时间窗: Up to 60 Days
次要结局
- Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area(Up to 60 Days)
研究者
研究点 (1)
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