Evaluation of the pharmacokinetics of caffeine, baicalin, baicalein, and sulfasalazine after oral administratio
- Conditions
- o diseases are investigated.
- Registration Number
- DRKS00031821
- Lead Sponsor
- Institut für Pharmazie; Biopharmazie & Pharmazeutische Technologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concentration of the applied substances (caffeine, baicalin or baicalein) or their metabolites (baicalin or baicalein, sulphapyridine) in blood plasma and, if applicable, in saliva (caffeine, sulphapyridine) over time.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters: tmax, cmax, AUC, analyte appearance times (tapp), elimination half-life (t1/2)<br><br>Concentration ratio of caffeine in saliva and blood plasma (saliva-plasma-ratio, s/p-ratio).