Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Opioid Induced Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions

Group Type EXPERIMENTAL

Naloxegol

Intervention Type DRUG

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation

B

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions

Group Type EXPERIMENTAL

Naloxegol

Intervention Type DRUG

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation

C

Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions

Group Type EXPERIMENTAL

Naloxegol

Intervention Type DRUG

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

Interventions

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Naloxegol

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation

Intervention Type DRUG

Naloxegol

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

Intervention Type DRUG

Eligibility Criteria

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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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes