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

Study Overview
=================
Brief Summary
-----------------
This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

Detailed 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

Official Title
-----------------
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

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: naproxen
* Drug: esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naproxen|250mg, oral dose|
|Drug: esomeprazole|20mg, oral dose|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed maximum concentration (Cmax) |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 
| time of maximum concentration (tmax) |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 
| area under the concentration-time curve from zero to time of last quantifiable concentration (AUC(0-t)) |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 
| area under the concentration-time curve from zero to infinity (AUC) |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 
| apparent terminal rate constant (λz), apparent terminal half-life (t1/2) |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 
| apparent systemic clearance after extravascular dosing (CL/F) |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 
| apparent volume of distribution following extravascular dosing (Vz/F) for naproxen and esomeprazole |  | Pharmacokinetic samples will be collected at pre-dose, 10, 20, 30, and 45 minutes post-dose, and 1, 1.5, 2,2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. The 72 hour post-dose sample will be collected at Visit 3 (Follow-up). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of Adverse events during the study as a measure of safety and tolerability |  | Collected from administration of VIMOVO (Visit 2 [Residential period] Day 1) until the end of the study, including follow-up | 
| Abnormalties in Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) as a measure of safety and tolerability |  | Labs will be taken from screening to follow up visit | 
| Abnormalities in Vital signs as a measure of safety and tolerability |  | From screening to follow up visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VIMOVO, Juvenile Idiopathic Arthritis, Pharmacokinetics, fasting state, Amount of VIMOVO in the blood, taken on empty stomach