An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers - Full Text View

Sponsor:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00442208

Purpose

Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.

Condition	Intervention	Phase
Healthy	Drug: PN 200	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study

Further study details as provided by Pozen:

Primary Outcome Measures:

To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH > 4.0)

Secondary Outcome Measures:

To evaluate the effect of different dosing times of PN 200 on the pharmacokinetic properties of omeprazole

Estimated Enrollment:	24
Study Start Date:	January 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This study is designed to evaluate the effect of different dosing times of PN 200 relative to food on the intragastric pH profile of PN 200. PN 200 contains immediate release omeprazole, which may be subject to acid degradation in the stomach. Food is known to have a buffering effect on acid and therefore may result in less degradation of immediate release omeprazole. Alternatively, food may decrease the absorption of omeprazole in the duodenum. The relative magnitude of these effects is unknown. The data from this study will aid in choosing the optimal timing of PN dosing relative to food in future studies. The study is not blinded because the primary endpoint (intragastric pH) is a physiological variable not believed to be readily influenced by conscious or subconscious subject control.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or non-lactating, non-pregnant female subjects who are 18-55 years of age
Female subjects are eligible for participation in the study if they are of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
  - Female sterilization or sterilization of male partner; or,
  - Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
  - Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
  - Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
  - Any other method with published data showing that the lowest expected failure rate is less than 1% per year
Physical examination findings within normal limits for age
Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed

Exclusion Criteria:

History of hypersensitivity, allergy or intolerance to omeprazole or other proton-pump inhibitors
History of hypersensitivity, allergy or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
History of peptic ulcer disease or other acid related gastrointestinal symptoms
Participation in any study of an investigational treatment in the 4 weeks before screening or participation in another study at any time during the period of this study
Any significant medical illness that would contraindicate participation in the study
Gastrointestinal disorder or surgery leading to impaired drug absorption
Any significant mental illness, such as schizophrenia or bipolar disorder
Cardio- or cerebrovascular disease, based on history or risk factors, or clinically significant ECG in the investigator's opinion
Personal or family history of an inherited or acquired bleeding disorder
Positive test result for H pylori at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442208

Locations

United States, North Carolina
Pozen Inc.
Chapel Hill, North Carolina, United States, 27517

Sponsors and Collaborators

Pozen

Investigators

Study Director:

David Taylor

Pozen, Inc.

More Information

No publications provided

Responsible Party:	Pozen Inc. ( David Taylor )
Study ID Numbers:	PN200-105
Study First Received:	February 28, 2007
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00442208 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pozen:

Healthy adults
Phase I

ClinicalTrials.gov processed this record on November 27, 2009