NCT01623609

Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

A Phase I, Randomised, Open-label, 3 Way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.

Detailed description

A Phase I, Randomised, Open-label, 3 way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.

Conditions

• Opioid Induced Constipation

Interventions

Type	Name	Description
DRUG	Naloxegol	Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation
DRUG	Naloxegol	Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-06-20
• Last updated: 2014-10-15

Locations

1 site across 1 country: United Kingdom