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

Juvenile Idiopathic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358383
• Other study ID #: D1120C00040
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2011
• Last updated: June 21, 2012
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• naproxen
250mg, oral dose
• esomeprazole
20mg, oral dose

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Primary	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).	No
Primary	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).	No
Primary	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).	No
Primary	apparent terminal rate constant (?z), 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).	No
Primary	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).	No
Primary	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).	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Abnormalities in Vital signs as a measure of safety and tolerability		From screening to follow up visit	Yes