Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ALO-02 (Oxycodone Naltrexone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01456507

B4531003

Details and patient eligibility

About

The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Full description

Bioavailability

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

Exclusion criteria

• Evidence or history of clinically significant diseases

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Experimental group

Description:

1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.

Treatment:

Drug: ALO-02 (Oxycodone Naltrexone)

Drug: ALO-02 (Oxycodone Naltrexone)

Drug: ALO-02 (Oxycodone Naltrexone)

B

Experimental group

Description:

1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).

Treatment:

Drug: ALO-02 (Oxycodone Naltrexone)

Drug: ALO-02 (Oxycodone Naltrexone)

Drug: ALO-02 (Oxycodone Naltrexone)

C

Experimental group

Description:

1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions.

Treatment:

Drug: ALO-02 (Oxycodone Naltrexone)

Drug: ALO-02 (Oxycodone Naltrexone)

Drug: ALO-02 (Oxycodone Naltrexone)