Pharmacokinetics Study of ALO-02 and OxyContin

Pfizer

Status and phase: Completed; Phase 1

Conditions: Management of Moderate to Severe Pain

Treatments: Drug: OxyContin; Drug: ALO-02; Drug: Naltrexone block

Study type: Interventional

Funder types: Industry

Identifiers

NCT01557257

B4531006

Details and patient eligibility

About

To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers

Enrollment: 13 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: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

40 mg ALO-02 capsule

Experimental group

Description:

Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block

Treatment:

Drug: ALO-02

Drug: ALO-02

Drug: Naltrexone block

Drug: Naltrexone block

Drug: Naltrexone block

80 mg ALO-02 capsule

Experimental group

Description:

Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block

Treatment:

Drug: ALO-02

Drug: ALO-02

Drug: Naltrexone block

Drug: Naltrexone block

Drug: Naltrexone block

40 mg OxyContin tablet

Experimental group

Description:

Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block

Treatment:

Drug: Naltrexone block

Drug: Naltrexone block

Drug: OxyContin

Drug: Naltrexone block