No diseases are investigated.
Conditions
Interventions
Group 1: Capsule 1: 25 mg 13C3 -caffeine and 50 mg sulfasalazine
Capsule 2 and 3: Baicalin medverita (containing 184 mg baicalin each, adding up to 368 mg baicalin in total)
postprandial intake
Group
Sponsors
Institut für Pharmazie; Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: tmax, cmax, AUC, analyte appearance times (tapp), elimination half-life (t1/2) Concentration ratio of caffeine in saliva and blood plasma (saliva-plasma-ratio, s/p-ratio). | — |
Countries
Germany
Contacts
Public ContactMichael Grimm
Institut für Pharmazie; Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed