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Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

NCT01623609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-10-15

No results posted yet for this study

Summary

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

Conditions

  • Opioid Induced Constipation

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Mark Sostek, MD · Astrazeneca Wilmington, US

  • Arpeat Kaviya, MBCHB, MRCP · Quintiles London UK

  • Bo Fransson, MD · Astrazeneca Sodertalje Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT01623609 on ClinicalTrials.gov