DRKS00031821已完成Unknown
Evaluation of the pharmacokinetics of caffeine, baicalin, baicalein, and sulfasalazine after oral administration
Institut für Pharmazie; Biopharmazie & Pharmazeutische Technologie0 个研究点目标入组 12 人开始时间: 2023年5月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •BMI: >= 18 kg/m² and <= 30 kg/m²
- •Minimum weight: 50 kg
- •Good health, which has been clinically evaluated to be normal by the responsible study physician
- •Complete immunisation against SARS-Cov2
- •Written consent form
排除标准
- •- Disorders/diseases that affect the swallowing process (e.g., severe dysphagia related to food and/or solid oral dosage forms)
- •- Gastrointestinal disease and/or pathologic changes that may interfere with gastric emptying
- •- Known or suspected stenosis, fistula, or mechanical obstruction within the gastrointestinal tract
- •- Surgical procedures on the gastrointestinal tract within the past 12 months
- •- Inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis)
- •- Known allergies or intolerances to any components of the standard meal or administered vehicles (especially caffeine, sulfasalazine, baicalin, mannitol, silica)
- •- alcohol or drug dependence
- •- Smokers with a cigarette consumption of more than 10 cigarettes per day
- •- Heavy tea or coffee drinkers (more than 1 L per day)
- •- Eating disorders such as anorexia, bulimia in the last 12 months
- •- Individuals with dietary habits that affect gastrointestinal motility (e.g., vegans, strict fasting)
- •- Positive pregnancy test or gravidity
- •- Breastfeeding
- •- Positive SARS-Cov 2 antigen rapid test or PCR test
- •- Individuals known to be unwilling or unable to reliably follow instructions
- •- Individuals who are unable to understand written and verbal instructions and teachings regarding the study risks they face
- •- Less than 14 days of acute illness
- •- Systemic use of medications, especially those that affect gastrointestinal tract function
- •- Taking antibiotics in the past 3 months
- •- Whole blood donation in the last 4 weeks
- •- Anemia (hemoglobin < 13 g/dL (8.07 mmol/L) in males or
- •< 12 g/dL (7.45 mmol/L) in female subjects).
- •- Increased liver function values (ALAT, ASAT, ?GT, bilirubin <2x ULN).
- •- Reduced renal function (eGFR MDRD < 60 mL/min/1.7 m 2 )
- •- Poor venous conditions that do not allow peripheral venous catheter to be placed and blood to be drawn regularly through it
- •No medications should be taken during the study and for 4 weeks prior to it that affect gastrointestinal motility and gastric function. Deviations from
- •this rule are possible if at least 10 half-lives have elapsed between the last drug and the start of the study are at least 10 half-lives.
- •Drugs of concern include, but are not limited to:
- •- Laxatives
- •- Antidiarrheal agents
- •- Prokinetic antiemetics
- •- Drugs with pronounced anticholinergic effects such as neuroleptics and
- •Antidepressants
- •- Opioid analgesics
- •- antibiotics
- •- Antacids, proton pump inhibitors, H2 antihistamines
- •- calcium antagonists
- •- beta blockers
- •- Nitrates
研究者
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