Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: naproxen; Drug: esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358383

D1120C00040

Details and patient eligibility

About

This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

Full description

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects aged 18 to 55 years
• Capable of understanding and complying with the Clinical Study Protocol
• Body mass index (BMI) of 19 to 30 kg/m2 and weight of 50 to 100 kg

Exclusion criteria

• Previous enrollment in the present study
• Receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study
• Female subjects with a positive urine pregnancy test

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)