Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

AstraZeneca42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Opioid Induced Constipation

Interventions

NaloxegolDRUG

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation

NaloxegolDRUG

Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 .

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.