Clinical trial NCT01358383: Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile Idiopathic Arthritis
Pharmacokinetics
VIMOVO
fasting state
Amount of VIMOVO in the blood
taken on empty stomach
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility 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

Primary outcomes:
measure: Observed maximum concentration (Cmax)
timeFrame: 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).
measure: time of maximum concentration (tmax)
timeFrame: 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).
measure: area under the concentration-time curve from zero to time of last quantifiable concentration (AUC(0-t))
timeFrame: 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).
measure: area under the concentration-time curve from zero to infinity (AUC)
timeFrame: 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).
measure: apparent terminal rate constant (λz), apparent terminal half-life (t1/2)
timeFrame: 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).
measure: apparent systemic clearance after extravascular dosing (CL/F)
timeFrame: 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).
measure: apparent volume of distribution following extravascular dosing (Vz/F) for naproxen and esomeprazole
timeFrame: 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 outcomes:
measure: Incidence and severity of Adverse events during the study as a measure of safety and tolerability
timeFrame: Collected from administration of VIMOVO (Visit 2 [Residential period] Day 1) until the end of the study, including follow-up
measure: Abnormalties in Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) as a measure of safety and tolerability
timeFrame: Labs will be taken from screening to follow up visit
measure: Abnormalities in Vital signs as a measure of safety and tolerability
timeFrame: From screening to follow up visit
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Mark Sostek
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Bo Fransson
role: STUDY_CHAIR
affiliation: Quintiles Phase I Services, Overland Park, Kansas
name: Kelly Craven
role: PRINCIPAL_INVESTIGATOR
References: