At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, 4-Period, 4-Treatment, Crossover, Single-Center, Single-Dose Bioavailability Study With Alternate Methods of Administration of Crushed Naloxegol Tablets, 25 mg and of a Naloxegol Solution Formulation, 25 mg, Compared to Whole Naloxegol Tablets, 25 mg, in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Naloxegol 25 mg tablet, crushed, suspended in water, given orally, Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube, and 2 other interventions for Bioavailability and Healthy Subjects. Completed, enrolled 44 participants across 1 site.
Detailed Summary
This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover, single-center, single-dose bioavailability study with alternate methods of administration of crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to whole naloxegol tablets, 25 mg, in healthy subjects. The main objective of this study is to determine the bioavailability of each of three alternative methods of naloxegol administration compared to whole naloxegol tablets given orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol
Study Details
Timeline
Interventions
naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally
naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube
naloxegol 25 mg (10 mL oral solution)
naloxegol 25 mg (1 tablet) whole tablet, given orally