Study Evaluating the Effect of Food on the Bioavailability of PN400 Components

POZEN

Status and phase: Completed; Phase 1

Conditions: Arthritis

Treatments: Drug: PN400

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676442

PN400-103

Details and patient eligibility

About

We will evaluate the effect of food on the bioavailability of the components of PN400

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female subjects between 18-55 years old as well as other standard inclusion criteria for a study of this nature.

Exclusion criteria

• Standard exclusion criteria for a study of this nature.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

1

Other group

Description:

PN400 administered after meal

Treatment:

Drug: PN400

2

Other group

Description:

PN400 administered prior to meal

Treatment:

Drug: PN400

3

Other group

Description:

PN400 administered prior to meal

Treatment:

Drug: PN400

4

Other group

Description:

PN400 followed by fast

Treatment:

Drug: PN400