No disease was investigated
Conditions
Interventions
Group 1: The healthy older volunteers take after an overnight fast a 9 mm press-coated tablet with 25 mg of food additive caffeine (stable isotope labeled) with 240 mL water
Group 2: The healthy older
Sponsors
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in this study arm have to fulfill all of the following criteria: • written informed consent (“Einverständniserklärung”) ICF must be btained before any assessment is performed • sex: male or female Study arm 1 and 2: • age: =65 years • body mass index: =18 kg/m² and = 30 kg/m² • healthy Study arm 3: • body mass index: =18 kg/m² and = 35 kg/m² • intake of 5 or more medications Study arm 4 and 5: • Age: =18 years and < 65 years • healthy
Exclusion criteria
Exclusion criteria: Study arm 1, 2, 4, 5: Subjects fulfilling any of the following criteria are not eligible for inclusion in this study: • Current participation in any clinical study including the use of any investigational drugs at the time of enrolment, or within 5 half-lives of enrolment, whichever is longer; or longer if required by local regulations • weight less than 45 kg • known allergic reactions or food intolerance to the tablets or meals ingredients • gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes • gastrointestinal diseases and/or pathological findings, which pose a risk for intake of solid oral dosage forms (e.g. esophagus stents, esophagus varices, hiatal hernia) • diseases and/or pathological findings and/or respective treatments that do not allow the intake of a solid meal or solid oral dosage forms (e.g. dysphagia, diseases needing tube feeding) • drug or alcohol addiction • smokers of 10 or more cigarettes per day • eating disorders e.g. anorexia, bulimia • heavy tea or coffee drinkers (more than 1L per day) • 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 study participation • cognitive impairments that disable subjects to give informed consent (e.g. Alzheimer’s disease, Dementia) • medical history of orthostatic dysregulation, fainting, or blackouts • medical history of upper gastrointestinal surgical procedure • chemotherapy • less than 2 weeks after last acute disease • less than 1 week after last blood donation • therapy with transdermal patches • therapy with drugs that affect the gastrointestinal motility (The use of oral contraceptives is permitted in study arms 4 and 5) • therapy with drugs that alter gastric pH Study arm 3: Subjects fulfilling any of the following criteria are not eligible for inclusion in this study: • weight less than 45 kg • known allergic reactions or food intolerance to the tablets or meals ingredients • gastrointestinal diseases and/or pathological findings, which pose a risk for intake of solid oral dosage forms (e.g. esophagus stents, esophagus varices, hiatal hernia) • diseases and/or pathological findings that do not allow the intake of a solid meal or solid oral dosage forms (e.g. dysphagia, diseases needing tube feeding) • drug or alcohol addiction • heavy tea or coffee drinkers (more than 1L per day) • 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 study participation • cognitive impairments that disable subjects to give informed consent (e.g. Alzheimer’s disease, Dementia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To acquire salivary caffeine kinetics in older individuals after intake of a press-coated tablet with 240 mL of water. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate gastric emptying rate from caffeine kinetics. To compare gastric emptying of water in older individuals (> 65 years) with gastric emptying of water in young healthy individuals. | — |
Countries
Germany
Contacts
Public ContactMichael Grimm
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed