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

June 21, 2012 updated by: AstraZeneca

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Observed maximum concentration (Cmax)
Time Frame: 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).
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)
Time Frame: 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).
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))
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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
Time Frame: 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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence and severity of Adverse events during the study as a measure of safety and tolerability
Time Frame: Collected from administration of VIMOVO (Visit 2 [Residential period] Day 1) until the end of the study, including follow-up
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
Time Frame: Labs will be taken from screening to follow up visit
Labs will be taken from screening to follow up visit
Abnormalities in Vital signs as a measure of safety and tolerability
Time Frame: From screening to follow up visit
From screening to follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bo Fransson, AstraZeneca
  • Principal Investigator: Kelly Craven, Quintiles Phase I Services, Overland Park, Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1120C00040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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