Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers

The entire study period for each subject will be 15 days, and consist of 3 periods defined as: Baseline (Day 1,2,3), Treatment (Day 3-10), and Recovery (Day 13-15). Healthy volunteers will be screened on Day 1 (and assessed for eligibility); Eligible subjects will be divided into 3 drug treatment groups pioglitazone, simvastatin and ibuprofen the positive control. The two treatment groups will consist of 4 healthy volunteers who meet the inclusion criteria. There will be 2 healthy volunteers in the positive control group. Group 1 will receive pioglitazone 30 mg once daily, Group 2 will receive simvastatin 40 mg daily and Group 3 the positive control will receive ibuprofen (15-23 mg/kg twice daily, maximum 3200 mg/day) during the Treatment period and serve as the positive control group. This dose is 25% of that prescribed to CF patients. As healthy volunteers are recruited, the first will be assigned to Group 1, the second to Group 2, and so on. After the third subject has been assigned to Group 3, this pattern of assignment will be repeated with subjects 4, 5 and 6, The following 4 healthy volunteers will be assigned to group 1 and 2 (7, 8, 9, 10).

Inclusion criteria

• ≥ 18 < 50 years of age
• Healthy volunteers must be in general good health as determined by a medical history.
• Ability to understand and sign the informed consent form
• Ability to adhere to the protocol.
• Willing to use an acceptable form of birth control

Exclusion criteria

• History of diabetes requiring insulin
• The use of NSAIDS (ibuprofen) or corticosteroids including inhaled steroids. Nasal steroids are acceptable.
• The use of statin lowering medications
• Active gingival disease (Active tooth or gum disease)
• Any chronic inflammatory condition that immuno compromises the volunteer as determined by medical history.
• Pregnant or planning to become pregnant