Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Opioid Induced Constipation

Treatments: Drug: Naloxegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01623609

D3820C00018

Details and patient eligibility

About

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

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Naloxegol

Drug: Naloxegol

B

Experimental group

Description:

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

Treatment:

Drug: Naloxegol

Drug: Naloxegol

C

Experimental group

Description:

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

Treatment:

Drug: Naloxegol

Drug: Naloxegol