NCT00338910已完成4 期
Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- AUC
研究概览
简要总结
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
详细描述
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Secondary objectives:
- Effect of budesonide on metronidazole steady-state PK (primarily described as area under the concentration-time-curve).
- Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration.
- Safety parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Caucasian origin
- •Age: between 18 and 55 years (inclusive)
- •Body mass index (BMI) within 18-30 kg/m²
- •Body weight at least 50 kg, at most 100 kg
- •Non-smoker (or ex-smoker ≥1 year), proven by urine cotinine <500 ng/ml
- •Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm
- •Normal ECG
- •Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial
- •Ability to communicate well with the investigator and comply with the requirements of the entire study
- •Written consent
排除标准
- •Subjects with contraindications for budesonide
- •Subjects with contraindications for metronidazole
- •History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics
- •History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
- •Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
- •Current smoker or ex-smoker ≤ 1 year
- •Excessive alcohol consumption (³ 35 g/day in males)
- •Abuse of drugs
- •Positive drug screening
- •Positive anti-HIV-test, HBsAg-test or anti-HCV-test
- •Proneness to orthostatic dysregulation, faintings, or blackouts
- •Heavy tea or coffee drinkers (more than 1 l ≈ 6 cups per day)
- •Administration of glucocorticosteroids within 6 weeks prior to study day 1 or during the trial
- •Repeated use of drugs during the last 4 weeks prior to study day 1 or during the trial, which might influence hepatic biotransformation
- •Any medication including OTC medication within the last 14 days prior to study day 1 or during the trial (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives)
- •Intake of grapefruit-containing food or beverages within 7 days prior to study day 1 or during the trial
- •Clinically relevant acute or chronic bacterial, fungal or viral infections
- •Surgery of the gastrointestinal tract which may interfere with drug absorption (not applicable for minor abdominal surgery such as e.g. appendectomy and herniotomy)
- •Vegetarian diet or other peculiar dietary habits which would preclude the subject's acceptance of standardized (non-vegetarian) meals
- •Subjects suspected or known not to follow instructions
- •Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •Patients known to be in financial difficulties, which could interfere with their appraisal of the informative instructions
- •Vulnerable subjects (e.g., persons kept in detention or persons who are depending on the sponsor or the investigator)
- •Blood donation or other blood loss of more than 400 ml within the last 2 months prior to study day 1
- •Participation in a clinical trial within the last 2 months prior to study day 1 (assessed by anamnestic inquiry)
结局指标
主要结局
AUC
次要结局
- other PK parameters
研究者
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