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A Bioavailability Study With Alternate Methods of Administration of Naloxegol Tablets, and Solution

NCT02446171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-03-10

Study results available
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Summary

This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover, single-center, single-dose bioavailability study with alternate methods of administration of crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to whole naloxegol tablets, 25 mg, in healthy subjects.

The main objective of this study is to determine the bioavailability of each of three alternative methods of naloxegol administration compared to whole naloxegol tablets given orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol

Conditions

  • Bioavailability
  • Healthy Subjects

Interventions

DRUG

Naloxegol 25 mg tablet, crushed, suspended in water, given orally

naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally

DRUG

Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube

naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube

DRUG

Naloxegol 25 mg (10 mL oral solution)

naloxegol 25 mg (10 mL oral solution)

DRUG

Naloxegol 25 mg tablet, given orally

naloxegol 25 mg (1 tablet) whole tablet, given orally

Sponsors & Collaborators

Principal Investigators

  • Rainard Fuhr, Dr. med. · PAREXEL International GmbH, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02446171 on ClinicalTrials.gov