Evaluation of gastric water emptying in fasted and fed state inyoung and advanced age populations with the use of a press-coated tablet containing caffeine

Not Applicable

• Conditions: o disease was investigated

• Registration Number: DRKS00033548
• Lead Sponsor: Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-11
• Study Start: 2024-06-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 31

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To acquire salivary caffeine kinetics in older individuals after<br>intake of a press-coated tablet with 240 mL of water.

Secondary Outcome Measures

Name	Time	Method
To evaluate gastric emptying rate from caffeine kinetics.<br>To compare gastric emptying of water in older individuals<br>(> 65 years) with gastric emptying of water in young healthy<br>individuals.