A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers

Exclusion Criteria

• •1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non seasonal allergies, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration, or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• •2. A history of allergic or adverse responses to diazepam or any comparable or similar product.
• •3. Subjects who (for whatever reason) have been on an abnormal diet (such as one that severely restricts specific basic food groups \[e.g., ketogenic diet\], limits calories \[e.g., fast\], and/or requires the use of daily supplements as a substitute for the foods typically eaten at mealtimes), during the four (4) weeks preceding the study.
• •4. Subjects who donated blood or plasma within 30 days of the first dose of study drug.
• •5. Participation in a clinical trial within 30 days prior to the first dose of study drug. Participation in an observational (non interventional) study is not excluded as long as there are no scheduling conflicts with this study.
• •6. Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
• •7. Use of any over the counter (OTC) medication, including vitamins, within seven (7) days prior to the first dose of the study drug or during the study, unless approved by the Principal Investigator.
• •8. Use of any prescription medication, including benzodiazepines, within 14 days prior to the first dose of study drug or during the study, with the exception of hormonal contraceptives for women of childbearing potential, unless approved by the Principal Investigator.
• •9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study drug or during the study.
• •10. Smoking or use of tobacco products within six (6) months prior to the first dose of study drug or during the study.
• •11. Female subjects who are trying to conceive, are pregnant, or are lactating.
• •12. Positive serum pregnancy test at Screening or urine pregnancy test prior to each administration of study drug for all women, regardless of childbearing potential.
• •13. Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol, drugs of abuse, or cotinine.