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

NCT01635608 | Completed Phase 1

• 2 other identifiers: MRI-probe drugs2011-000228-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Motility Disorder

Keywords

Pharmacokinetics; Talinolol; Amoxicillin; Acetaminophen; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Correlation between volume of water in stomach and AUC of study medication

  0 to 48 h

Secondary Outcomes (4)

• area under the concentrations-time curve (AUC)

  0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105 min and 2, 3, 4, 6, 8, 12, 24 and 48 h after drug administration

• maximum concentration (Cmax)

  0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105 min and 2, 3, 4, 6, 8, 12, 24 and 48 h after drug administration

• volumen of water in stomach

  before and 1.5, 6.5, 11.5, 16.5, 21.5, 26.5, 31.5, 36.5, 41.5, 46.5, 51.5, 56.5, 61.5, 66.5, 71.5, 76.5, 81.5, 86.5, 91.5, 96.5, 101.5, 106.5, 111.5, and 116.5 min after administration of the study medication

• volumen of water in small intestine

  before and 1.5, 6.5, 11.5, 16.5, 21.5, 26.5, 31.5, 36.5, 41.5, 46.5, 51.5, 56.5, 61.5, 66.5, 71.5, 76.5, 81.5, 86.5, 91.5, 96.5, 101.5, 106.5, 111.5, and 116.5 min after administration of the study medication

Study Arms (2)

non-caloric water

ACTIVE COMPARATOR

500 mg paracetamol, 50 mg talinolol and 500 mg amoxicillin dissolved in 240 ml non-caloric water immediately before administration after overnight fasting

Drug: Acetaminophen; Drug: Talinolol; Drug: Amoxicillin; Other: non-caloric water

caloric water

ACTIVE COMPARATOR

500 mg paracetamol, 50 mg talinolol and 500 mg amoxicillin dissolved in 240 ml caloric water immediately before oral administration after overnight fasting

Drug: Acetaminophen; Drug: Talinolol; Drug: Amoxicillin; Other: caloric water

Interventions

Acetaminophen DRUG

administration of 500 mg paracetamol

caloric water; non-caloric water

Talinolol DRUG

administration of 50 mg talinolol

caloric water; non-caloric water

Amoxicillin DRUG

administration of 500 mg amoxicillin

caloric water; non-caloric water

non-caloric water OTHER

administration of 240 ml water

non-caloric water

caloric water OTHER

administration of 240 ml caloric water (containing 25.5 g sucrose)

caloric water

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald

Greifswald, Meckleburg-Vorpommern, 17487, Germany

Location

MeSH Terms

Interventions

Acetaminophen; talinolol; Amoxicillin

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 9, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

DE (1)