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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358383
First Posted: May 23, 2011
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

Condition Intervention Phase
Juvenile Idiopathic Arthritis Drug: naproxen Drug: esomeprazole Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Abnormalities in Vital signs as a measure of safety and tolerability [ Time Frame: From screening to follow up visit ]

Enrollment: 28
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: naproxen
    250mg, oral dose
    Drug: esomeprazole
    20mg, oral dose
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358383


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek AstraZeneca
Study Chair: Bo Fransson AstraZeneca
Principal Investigator: Kelly Craven Quintiles Phase I Services, Overland Park, Kansas
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01358383     History of Changes
Other Study ID Numbers: D1120C00040
First Submitted: May 16, 2011
First Posted: May 23, 2011
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Juvenile Idiopathic Arthritis
Pharmacokinetics
VIMOVO
fasting state
Amount of VIMOVO in the blood
taken on empty stomach

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Esomeprazole
Naproxen
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors