Open label, healthy volunteers, bioequivalence study with naloxegol
Study identifier:D3820C00018
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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.
Medical condition
Opioid induced constipation
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Naloxegol
Sex
All
Actual Enrollment
42
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jul 2012
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Sept 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: A Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions | Drug: Naloxegol Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation |
| Experimental: B Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions | Drug: Naloxegol Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation |
| Experimental: C Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions | Drug: Naloxegol Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet |
Contacts
Investigators
Principal Investigator
Mark Sostek
Astrazeneca Wilmington, US
