Pharmacokinetics of Atropine Oral Gel

Exclusion Criteria

• •1. Female subjects who are pregnant or nursing at the time of screening
• •2. Chemotherapy or radiotherapy treatment within the last three months
• •3. Severe renal impairment defined as estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 calculated using the CKD-EPI creatinine equation:
• •eGFR (mL/min/1.73 m2) = 141 x min(Scr/k, 1)α x max(Scr/k,1)-1.209 x 0.993Age x 1.018 \[if female\] x 1.159 \[if black\]
• •Where,
• •1. k=0.7 if female
• •2. k=0.9 if male
• •3. α=-0.329 if female
• •4. α=-0.411 if male
• •5. min=The minimum of Scr/k or 1
• •6. max=The maximum of Scr/k or 1
• •7. Scr = serum creatinine (mg/dL)
• •4. Acute hepatitis in the prior 6 months, a prior history of cirrhosis, acute hepatic failure, or acute decompensation of chronic hepatic failure; and/or any of the following blood test results, for any individual, when assessed for eligibility:
• •1. Bilirubin \> 3 x upper limit of normal (ULN). \[ULN for bilirubin = 1.4 mg/dL\]
• •2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 3 x ULN values used by the laboratory performing the test. \[ULN for AST = 40 U/L, ULN for ALT = 60 U/L\]
• •3. Alkaline phosphatase (ALP) \> 3 x ULN \[ULN for ALP = 126 U/L)
• •5. Deforming lesions of the oral cavity
• •6. Previous head and/or neck radiotherapy
• •7. Patients with a history of hypersensitivity reaction towards atropine and/or Carbopol 980 NF or any carbomers
• •8. Patients with heart conditions such as congenital heart disease, heart failure, coronary heart disease, myocardial infarction, and arrhythmia
• •9. Patients with acute glaucoma that may be exacerbated with atropine administration.
• •10. Patients with partial pyloric stenosis or other diseases related to gastrointestinal obstruction.
• •11. Patients diagnosed with urinary retention
• •12. Treatment with any other investigational drug during the 30 days prior to enrollment into the study
• •13. Patients receiving anticholinergic medications at baseline.
• •14. Patients who are receiving immunosuppression
• •15. Patients who are actively being treated for an infection
• •16. Patients with a history of salivary gland obstruction or stones
• •17. Patients with a history of chronic lung disease or chronic obstructive pulmonary disease (COPD)
• •18. Patients with an artificial airway (tracheostomy)
• •19. Patient taking monoamine oxidase inhibitors