A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Bioequivalence; Healthy Volunteers

Treatments: Drug: Marketed enteric-coated naproxen formulation; Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01331993

D1120C00030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 6 patient groups

1

Experimental group

Description:

Treatment order : A, B, C

Treatment:

Drug: VIMOVO (Patheon)

Drug: VIMOVO (AstraZeneca)

Drug: Marketed enteric-coated naproxen formulation

2

Experimental group

Description:

Treatment order : B, C, A

Treatment:

Drug: VIMOVO (Patheon)

Drug: VIMOVO (AstraZeneca)

Drug: Marketed enteric-coated naproxen formulation

3

Experimental group

Description:

Treatment order : C, A, B

Treatment:

Drug: VIMOVO (Patheon)

Drug: VIMOVO (AstraZeneca)

Drug: Marketed enteric-coated naproxen formulation

4

Experimental group

Description:

Treatment order : A, C, B

Treatment:

Drug: VIMOVO (Patheon)

Drug: VIMOVO (AstraZeneca)

Drug: Marketed enteric-coated naproxen formulation

5

Experimental group

Description:

Treatment order : B, A, C

Treatment:

Drug: VIMOVO (Patheon)

Drug: VIMOVO (AstraZeneca)

Drug: Marketed enteric-coated naproxen formulation

6

Experimental group

Description:

Treatment order : C, B, A

Treatment:

Drug: VIMOVO (Patheon)

Drug: VIMOVO (AstraZeneca)

Drug: Marketed enteric-coated naproxen formulation