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Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums

NCT03012763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-01-06

No results posted yet for this study

Summary

The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine, given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml grapefruit juice prior to ingestion and to visualize the localization and to measure the filling volume of stomach, small intestine as well as ascending, transverse and descending colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water (non-caloric water), after administration of 240 ml caloric drink and after administration of 240 ml grapefruit juice.

Conditions

  • Pharmacokinetics
  • Magnetic Resonance Imaging
  • Administration, Oral

Interventions

DRUG

Paracetamol

Oral administration of 250 mg paracetamol

DRUG

Sulfasalazine

Oral administration of 50 mg sulfasalazine

DRUG

Fexofenadine

Oral administration of 120 mg fexofenadine

DRUG

Valsartan

Oral administration of 40 mg valsartan

DEVICE

non-caloric water

Oral administration of 240 ml non-caloric water

DEVICE

caloric drink

Oral administration of 240 ml caloric drink

DEVICE

grapefruit juice

Oral administration of 240 ml grapefruit juice

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-01-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012763 on ClinicalTrials.gov