Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Juvenile Idiopathic Arthritis
- Registration Number
- NCT01358383
- Lead Sponsor
- AstraZeneca
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Overland Park, Kansas, United States