In vivo evaluation of hard gelatin and hypromellose capsule disintegration in fasted state after intake with different fluids by salivary caffeine method
- Conditions
- no disease/ no health related problem
- Registration Number
- DRKS00033547
- Lead Sponsor
- Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
•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
•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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method