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A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Three-Period, Three-Treatment, Six-Sequence Randomized Crossover Study of the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers",

NCT01364558•University of Minnesota

View on ClinicalTrials.gov

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

Detailed Description

Diazepam is a medication that is used for the treatment of seizures. It was approved by the Food and Drug Administration (FDA) for use in the United States and is currently sold as Valium® tablets, Diazepam Injection and Diastat® rectal gel. This study will evaluate two intranasal (nasal spray) formulations of diazepam which will be supplied by Neurelis, Inc. 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. "Bioavailability" is a measure of how much drug is absorbed and present in the blood. "Pharmacokinetics" means to study the way a drug enters and leaves the blood and tissues over time

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
+3 more criteria

Locations (1)

Prism Clinical Research Unit

Saint Paul, Minnesota, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

November 1, 2019

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Diazepam

DRUG

Diazepam

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers