A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Diazepam; Diazepam
Intervention description: Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.; IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.
Intervention MeSH terms: Diazepam
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this clinical research study is to assess the bioavailability and
      pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and
      injectable diazepam after intravenous (I.V.) administration
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects between the ages of 18 and 45 years (inclusive).

          2. Written informed consent to participate in the study.

          3. Body mass index (BMI) between 19 and 30 kg/m², inclusive.

          4. Female subjects of childbearing potential, defined as not surgically sterile or at
             least two years (2) postmenopausal, must agree to use one of the following forms of
             contraception from three (3) months prior through 12 days following the last dose of
             study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom,
             diaphragm with spermicide), IUD, or vasectomized partner (six months minimum).
             Subjects must have used the same method for at least three (3) months prior to
             starting the study.

          5. No clinically significant abnormal findings in the medical history, on the physical
             examination, electrocardiogram (ECG), or clinical laboratory results during Screening.

          6. Subjects must agree to return to the study site for all study visits, including the
             three (3) confinement periods, and must be willing to comply with all required study
             procedures.

        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.