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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01358383
First received: May 16, 2011
Last updated: June 21, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Abnormalities in Vital signs as a measure of safety and tolerability [ Time Frame: From screening to follow up visit ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01358383     History of Changes
Other Study ID Numbers: D1120C00040
Study First Received: May 16, 2011
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Esomeprazole
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014