Basic research on the absorbability of substances in the small intestine
Conditions
Interventions
Group 1: Intake of a permeation enhancing, gastro-resistant formulation with 240 ml tap water in the fasted state. The dosage form contains 20 mg cyanocobalamin, up to 100 mg thiamine hydrochloride, u
Sponsors
Universität Greifswald - Institut für Pharmazie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers, BMI 18-29,9 kg/m^2, minimum weight 50 kg
Exclusion criteria
Exclusion criteria: - Disorders/diseases affecting the swallowing process (e.g., severe dysphagia in relation to food and/or solid oral dosage forms) - Claustrophobia - Gastrointestinal disorders and/or pathological changes that could interfere with gastric emptying - Known or suspected stenoses, fistulas, or mechanical obstructions within the gastrointestinal tract - Liver diseases - Surgical procedures on the gastrointestinal tract within the last 12 months - Inflammatory bowel diseases (Crohn's disease, ulcerative colitis, or diverticulitis) - Implanted or portable electromechanical medical devices such as pacemakers, defibrillators, or infusion pumps - Large dark tattoos - Known allergies or intolerances to the ingredients of the tablets administered in the capsules or the ingredients of the injection solutions - Alcohol or drug addiction - Smokers who consume more than 10 cigarettes per day - Eating disorders such as anorexia, bulimia - Positive pregnancy test - Breastfeeding - Individuals who are known to be unwilling or unable to follow instructions reliably - Individuals who are unable to understand written and verbal instructions and information regarding the risks of the study - Less than 14 days after acute illness - Systemic use of medication, especially medication that affects the function of the gastrointestinal tract - Simultaneous participation in interventional research projects; the interval between previous participation in other studies should not be less than 14 days - Whole blood donation in the last 4 weeks - Anemia (hemoglobin < 13 g/dL (8.07 mmol/L) in male subjects or < 12 g/dL (7.45 mmol/L) in female subjects) - Poor venous conditions that do not allow a peripheral venous catheter to be inserted and blood to be drawn regularly through it During the study and for 4 weeks prior to it, no drugs that affect gastrointestinal motility and stomach function may be taken. Exceptions to this rule are possible if there are at least 10 half-lives between the last dose of the drug and the start of the study. The affected drugs include, among others: - Laxatives - Antidiarrheals - 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 During the study and one week prior to it, no medications containing cyanocobalamin or thiamine may be taken. In addition, no foods to which cyanocobalamin or thiamine have been artificially added as nutritional supplements may be consumed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of systemic exposure to cyanocobalamin and thiamine after administration of a permeation enhancing, gastro-resistant formulation or a gastro-resistant formulation by measuring plasma concentrations at defined time points and relating the areas under the curves to the areas resulting from intravenous administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of disintegration and release of the oral dosage forms by measuring 13C3-caffeine and decanoate in plasma. Determination of the relationship between the release rates of 13C3-caffeine or decanoate and the plasma exposures of cyanocobalamin and thiamine from the respective formulations. Determination of the relationship between disintegration time and disintegration site according to MRI imaging with plasma exposures of cyanocobalamin and thiamine from the respective formulations. | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Universität Greifswald - Institut für Pharmazie
Outcome results
None listed