Overview
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
Status:
Completed
Completed
Trial end date:
2012-09-01
2012-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
AstraZenecaTreatments:
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 .