NCT03012763

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

Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan After Oral Administration Using 240 ml Non-caloric Water, a Carbohydrate Enriched Drink and Grapefruit Juice in Correlation to the Intestinal Availability of Water as Quantified by MRI-based Volumetry in 9 Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-01-01
• First posted: 2017-01-06
• Last updated: 2017-01-06