Absorption of Paracetamol, Talinolol and Amoxicillin After Oral Administration Using Non-caloric and Caloric Water

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To visualize the localization and to measure the volume of water in the small intestine by T2-weighted MRI imaging after oral administration of 240 ml water (non-caloric water) and after administration of 240 ml water containing 25.5 g sucrose (105 kcal, caloric water).

To measure pharmacokinetics of the probe-drugs paracetamol, talinolol and amoxicillin after oral administration dissolved in 240 ml non-caloric and in 240 ml caloric water.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medicine Greifswald
• Treatments: Acetaminophen; Amoxicillin; Talinolol

Criteria

Inclusion Criteria:

• age: 18 - 45 years

• sex: male and female

• ethnic origin: white

• body weight between 19 and 27 kg/m²

• good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state

• written informed consent

Exclusion Criteria:

• weight less than 45 kg

• claustrophobia

• cardiac pacemakers, metallic implants or metal-containing tatoos

• known allergic reactions to the active ingredients used or to constituents of the study medication

• bronchial asthma (all stages)

• existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. tachycardia)

• hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication

• gastrointestinal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication

• drug or alcohol dependence

• positive drug or alcohol screening

• smokers of 10 or more cigarettes per day

• positive results in HIV, HBV and HCV screenings

• subjects who are on a diet which could affect the pharmacokinetics of the drug

• heavy tea or coffee drinkers (more than 1L per day)

• lactation and pregnancy test positive or not performed

• subjects suspected or known not to follow instructions

• subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

• subjects liable to orthostatic dysregulation, fainting, or blackouts

• participation in a clinical trial during the last 3 months prior to the start of the study

• less than 14 days after last acute disease

• less than 3 months after last blood donation

• any systemically available medication within 2 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites (except oral contraceptives)

• intake of grapefruit or poppy seeds containing products within 14 days prior to administration