Overview

Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Naloxegol
Criteria
Inclusion Criteria:

- Female non-pregnant, non-lactating.

- Volunteers with suitable veins for cannulation or repeated venipuncture.

- Male healthy volunteers should be willing to use barrier contraception ie, condoms,
from the first day of dosing until 3 months after dosing with the investigational
product.

- The female partner should use contraception during this period.

Exclusion Criteria:

- History of any clinically significant disease or disorder.

- Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of investigational product.

- Volunteers who have smoked or used nicotine products within the previous 3 months from
the date of screening.

- Any clinically significant abnormalities in clinical chemistry, haematology, or
urinalysis results as judged by the Investigator .