no disease/ no health related problem
Conditions
Interventions
Group 1: Intake of hard gelatin capsule and press-coated tablet with 25 mg caffeine each together with 240 mL warm tap water (50°C) to fasted subjects, with subsequent self reliant salivary sampling
Sponsors
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Body Mass Index (BMI) between 18.0 and 29.99 kg/m² • Good health as evidenced by the results of the physical examination, which are judged by the responsible physician not to differ in a clinically relevant way from the normal state
Exclusion criteria
Exclusion criteria: • Current participation in any clinical study including the use of any investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations • known allergic reactions or food intolerance to the capsules or fluids ingredients • problems to swallow large capsules • gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes • drug or alcohol addiction • smokers of 10 or more cigarettes per day • subjects who are on a diet which could affect gastrointestinal motility (e.g. vegan) • eating disorders e.g. anorexia, bulimia • lactating and pregnant women (positive urine test) • subjects suspected or known not to follow instructions • subjects who are unable to understand the written and verbal instructions, regarding the risks and inconveniences they will be exposed to as a result of their participation in the study • less than 2 weeks after last acute disease • less than 1 week after last blood donation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disintegration time from caffeine concentration (appearance) in saliva (as measured by validated LC-MS/MS method), the influence of tested fluids in fasted state on the release and absorption of caffeine from two different capsules’ types by measuring the caffeine concentration in saliva (caffeine kinetics) | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastric emptying of the co-administered fluids by caffeine ratio AUC(0-30)/AUC(0-tlast) | — |
Countries
Germany
Contacts
Public ContactMichael Grimm
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Outcome results
None listed