Juvenile Idiopathic Arthritis (JIA)
Conditions
Brief summary
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Detailed description
Study with completed results acquired from Horizon in 2024.
Interventions
DRUGVIMOVO 250/20
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
DRUGVIMOVO 375/20
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
DRUGVIMOVO 500/20
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate. * Male and female adolescents aged 12 to 16 years at the time of enrollment. * Diagnosed with JIA, including all the International League of Associations for Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor \[RF\]+ and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis, and systemic arthritis. * Based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with VIMOVO. * Body weight \> 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.
Exclusion criteria
* In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug. * Currently taking (ie, within 4 weeks prior to start of drug) naproxen \> 20 mg/kg/day or \> 1000 mg total daily dose. * Hemoglobin ≤ 8.5 g/dL. * Individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors. * Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days. | An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) | pre-dose, and up to 3 hours post-dose | — |
| PK of Esomeprazole: Oral Plasma Clearance (CL/F) | pre-dose, and up to 3 hours post-dose | — |
| PK of Esomeprazole: Absorption Rate Constant (Ka) | pre-dose, and up to 3 hours post-dose | — |
| PK of Esomeprazole: Oral Volume of Distribution (V/F) | pre-dose, and up to 3 hours post-dose | — |
| PK of Naproxen: Trough Plasma Concentrations | Month 1 and Month 3: pre-dose, and up to 3 hours post-dose | Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant. |
Countries
United States
Participant flow
Pre-assignment details
A total of 51 participants signed informed consent; 5 participants were not assigned to treatment (eligibility criteria not fulfilled).
Participants by arm
| Arm | Count |
|---|---|
| VIMOVO 250 mg/20 mg 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months | 4 |
| VIMOVO 375 mg/20 mg 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months | 20 |
| VIMOVO 500 mg/20 mg 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months | 22 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | VIMOVO 250 mg/20 mg | VIMOVO 375 mg/20 mg | VIMOVO 500 mg/20 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 12.8 years STANDARD_DEVIATION 0.96 | 13.6 years STANDARD_DEVIATION 1.47 | 13.8 years STANDARD_DEVIATION 1.33 | 13.6 years STANDARD_DEVIATION 1.37 |
| Age, Customized Age Group 12 years old | 2 Participants | 7 Participants | 4 Participants | 13 Participants |
| Age, Customized Age Group 13 years old | 1 Participants | 4 Participants | 7 Participants | 12 Participants |
| Age, Customized Age Group 14 years old | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Age, Customized Age Group 15 years old | 0 Participants | 5 Participants | 7 Participants | 12 Participants |
| Age, Customized Age Group 16 years old | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 3 Participants | 15 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 16 / 20 | 17 / 22 | 37 / 46 |
| serious Total, serious adverse events | 0 / 4 | 1 / 20 | 0 / 22 | 1 / 46 |
Outcome results
Primary
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.
Time frame: SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.
Population: Safety analysis set: all participants who received at least 1 dose of study drug; participants were categorized according to the treatment medication they actually took.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE | 4 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Mild TEAE | 1 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Moderate TEAE | 3 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Severe TEAE | 0 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE | 1 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any SAE | 0 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related SAE | 0 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to death | 0 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to DC of study drug | 1 participants |
| VIMOVO 250 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE leading to DC of study drug | 1 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Moderate TEAE | 6 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to DC of study drug | 1 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Severe TEAE | 1 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE | 6 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any SAE | 1 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related SAE | 1 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE leading to DC of study drug | 1 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to death | 0 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE | 16 participants |
| VIMOVO 375 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Mild TEAE | 9 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to death | 0 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related SAE | 0 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE leading to DC of study drug | 1 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE | 17 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Severe TEAE | 0 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any SAE | 0 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to DC of study drug | 2 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Mild TEAE | 8 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE | 4 participants |
| VIMOVO 500 mg/20 mg | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Moderate TEAE | 9 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE | 11 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to death | 0 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any SAE | 1 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related TEAE leading to DC of study drug | 3 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any related SAE | 1 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Mild TEAE | 18 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Moderate TEAE | 18 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Severe TEAE | 1 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE | 37 participants |
| Total | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug | Any TEAE leading to DC of study drug | 4 participants |
Secondary
Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])
Time frame: pre-dose, and up to 3 hours post-dose
Population: PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VIMOVO 250 mg/20 mg | Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) | 2.2 hr*µmol/L | Geometric Coefficient of Variation 92 |
| VIMOVO 375 mg/20 mg | Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) | 1.3 hr*µmol/L | Geometric Coefficient of Variation 170 |
| VIMOVO 500 mg/20 mg | Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) | 1.2 hr*µmol/L | Geometric Coefficient of Variation 150 |
| Total | Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) | 1.3 hr*µmol/L | Geometric Coefficient of Variation 150 |
Secondary
PK of Esomeprazole: Absorption Rate Constant (Ka)
Time frame: pre-dose, and up to 3 hours post-dose
Population: PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VIMOVO 250 mg/20 mg | PK of Esomeprazole: Absorption Rate Constant (Ka) | 2.8 h^-1 | Geometric Coefficient of Variation 140 |
| VIMOVO 375 mg/20 mg | PK of Esomeprazole: Absorption Rate Constant (Ka) | 2.6 h^-1 | Geometric Coefficient of Variation 83 |
| VIMOVO 500 mg/20 mg | PK of Esomeprazole: Absorption Rate Constant (Ka) | 4.1 h^-1 | Geometric Coefficient of Variation 70 |
| Total | PK of Esomeprazole: Absorption Rate Constant (Ka) | 3.3 h^-1 | Geometric Coefficient of Variation 84 |
Secondary
PK of Esomeprazole: Oral Plasma Clearance (CL/F)
Time frame: pre-dose, and up to 3 hours post-dose
Population: PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VIMOVO 250 mg/20 mg | PK of Esomeprazole: Oral Plasma Clearance (CL/F) | 27 L/h | Geometric Coefficient of Variation 92 |
| VIMOVO 375 mg/20 mg | PK of Esomeprazole: Oral Plasma Clearance (CL/F) | 44 L/h | Geometric Coefficient of Variation 170 |
| VIMOVO 500 mg/20 mg | PK of Esomeprazole: Oral Plasma Clearance (CL/F) | 47 L/h | Geometric Coefficient of Variation 150 |
| Total | PK of Esomeprazole: Oral Plasma Clearance (CL/F) | 43 L/h | Geometric Coefficient of Variation 150 |
Secondary
PK of Esomeprazole: Oral Volume of Distribution (V/F)
Time frame: pre-dose, and up to 3 hours post-dose
Population: PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VIMOVO 250 mg/20 mg | PK of Esomeprazole: Oral Volume of Distribution (V/F) | 28 L | Geometric Coefficient of Variation 240 |
| VIMOVO 375 mg/20 mg | PK of Esomeprazole: Oral Volume of Distribution (V/F) | 61 L | Geometric Coefficient of Variation 120 |
| VIMOVO 500 mg/20 mg | PK of Esomeprazole: Oral Volume of Distribution (V/F) | 57 L | Geometric Coefficient of Variation 130 |
| Total | PK of Esomeprazole: Oral Volume of Distribution (V/F) | 55 L | Geometric Coefficient of Variation 130 |
Secondary
PK of Naproxen: Trough Plasma Concentrations
Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.
Time frame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose
Population: PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| VIMOVO 250 mg/20 mg | PK of Naproxen: Trough Plasma Concentrations | Month 3 | 63.16 µg/mL | Geometric Coefficient of Variation 67.3 |
| VIMOVO 250 mg/20 mg | PK of Naproxen: Trough Plasma Concentrations | Month 1 | 63.09 µg/mL | Geometric Coefficient of Variation 40.1 |
| VIMOVO 375 mg/20 mg | PK of Naproxen: Trough Plasma Concentrations | Month 3 | 33.91 µg/mL | Geometric Coefficient of Variation 476 |
| VIMOVO 375 mg/20 mg | PK of Naproxen: Trough Plasma Concentrations | Month 1 | 19.29 µg/mL | Geometric Coefficient of Variation 1334.9 |
| VIMOVO 500 mg/20 mg | PK of Naproxen: Trough Plasma Concentrations | Month 3 | 40.69 µg/mL | Geometric Coefficient of Variation 325.4 |
| VIMOVO 500 mg/20 mg | PK of Naproxen: Trough Plasma Concentrations | Month 1 | 40.71 µg/mL | Geometric Coefficient of Variation 277.3 |