Juvenile Idiopathic Arthritis
Conditions
Keywords
Juvenile Idiopathic Arthritis, Pharmacokinetics, VIMOVO, fasting state, Amount of VIMOVO in the blood, taken on empty stomach
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
Interventions
DRUGnaproxen
250mg, oral dose
DRUGesomeprazole
20mg, oral dose
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). |
| 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). |
| 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). |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed