Clinical trial NCT01331993: A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
Official title: A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Bioequivalence
Keywords: Phase 1
crossover
bioequivalence
naproxen
esomeprazole
vimovo
healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.

Detailed description: A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteer, aged 18 - 55 years (inclusive)
* Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.
* Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study
* Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)

Exclusion Criteria:

* Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening
* Uncontrolled hypertension defined as resting systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg at screening or admission to Period 1
* Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms
* Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption

Primary outcomes:
measure: Change in area under the plasma concentration-time curve (AUC) from time zero to infinity
timeFrame: Pre-dose to Day 4
Secondary outcomes:
measure: Number of subjects with Adverse Events as a measure of Safety and Tolerability
timeFrame: Day 1
measure: Number of subjects with Adverse Events as a measure of Safety and Tolerability
timeFrame: Day 2
measure: Number of subjects with Adverse Events as a measure of Safety and Tolerability
timeFrame: Day 3
measure: Number of subjects with Adverse Events as a measure of Safety and Tolerability
timeFrame: Day 4
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca, Wilmington, USA
name: Stepehn Kanes
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK
name: Kingsley Urakpo, MD
role: PRINCIPAL_INVESTIGATOR
References: