Status:
COMPLETED
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
Lead Sponsor:
POZEN
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00442208
Start Date
January 1 2007
End Date
February 1 2008
Last Update
April 22 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pozen Inc.
Chapel Hill, North Carolina, United States, 27517