Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101

Exclusion Criteria

• •A female who is pregnant, plans to become pregnant during the study, or is breastfeeding a child;
• •Are actively being treated for periodontitis, gingivitis or caries;
• •Have severe periodontal disease, as characterized by purulent exudates, generalized mobility, or severe recession;
• •Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal (GI), endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions, that might interfere with the study results in the investigator's opinion;
• •Any condition which, in the investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study;
• •Have known or suspected allergies to oral care products, toothpaste, or ingredients in toothpaste;
• •Immunization within 10 days of Day 1;
• •Anticipated need for surgery or hospitalization during the study;
• •Consumed alcohol within 48 hours prior to Day 1 or refuses to abstain from alcohol throughout the duration of the study;
• •History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco/nicotine equivalent) within 3 months of screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study;
• •Consumed caffeine (i.e., coffee, tea, caffeinated soda, chocolate) within 48 hours prior to Day 1 or refuses to abstain from caffeine throughout the duration of the study;
• •Donation or loss of blood (excluding volume drawn at screening) of ≥ 450 mL within 3 months of Day 1;
• •Active or lifetime infection (e.g., negative test for human immunodeficiency virus (HIV) and hepatitis, and no history of tuberculosis and syphilis) or a history of severe infection during the 30 days prior to screening;
• •Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment;
• •Is unwilling or unable to refrain from using prescription medications for 30 days prior to Day 1 or over the counter medications, herbal preparations, and supplements for 14 days prior to Day 1 (excluding permitted forms of contraception and occasional use of acetaminophen \[up to 2 g in 24 hours\]);
• •Inability or unlikeliness of the subject to comply with the dose schedule and study evaluations, in the opinion of the investigator;
• •Is currently participating in any clinical trial;
• •Has received any investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to study Day 1;
• •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data;
• •Inability of the subject (or legally authorized representative) to comprehend the electronic informed consent form (eICF) or unwillingness to sign the eICF; and/or
• •Subject meets eligibility criteria, but study is filled