Scopolamine Patch Pharmacokinetics in Healthy Adults

Inclusion Criteria

• Men or non-pregnant women of any ethnic background between the age of 18 and 65 years old.
• Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and are not currently using tobacco products.
• Provide written informed consent before initiation of any study procedures.
• Available for follow-up for the planned duration of the study.
• Able to communicate well with the investigators.
• Able to adhere to the study protocol schedule, study restrictions and examination schedule.
• Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
• Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
• Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
• Negative urine drug screening test.
• Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm).
• Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST, and total bilirubin.
• Have normal screening laboratories for urine protein and urine glucose.
• Female subjects must be of non-childbearing potential (defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year [no bleeding for 12 consecutive months]), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of the first day of each study treatment session, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
• Agrees not to participate in another clinical study during the study period unless the study is in the follow up phase and it has been 1 month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 1 month after last procedure day.
• Agrees not to donate blood to a blood bank throughout participation in the study and for at least 2 months after last procedure day.
• Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block (sinus rhythm is between 55-100 beats per minute).

Exclusion Criteria

• Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any procedure session.
• Smokers (current use or use over the previous 12 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes)).
• Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow up phase and it has been ≥ 1 month since the subject received any experimental agents or treatments..
• Abnormal vital signs, defined as:
• Hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) at rest on 2 separate days.
• Heart rate 38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the scopolamine TDDS.
• History of chronic obstructive pulmonary disease.
• Positive urine drug screening test.
• Use of any prescription medicatio