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 .