EUCTR2008-001575-30-GB
Active, not recruiting
Not Applicable
A randomised, open-label, single-centre, pharmacokinetic study of a single dose of lorazepam administered by the intranasal and buccal route in healthy adult volunteers - Lorazepam Pharmacokinetics after Intranasal and Buccal Administration
niversity of Nottingham0 sites12 target enrollmentJuly 25, 2008
ConditionsStatus epilepticusMedDRA version: 9.1Level: LLTClassification code 10041962Term: Status epilepticus
DrugsAtivan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Status epilepticus
- Sponsor
- niversity of Nottingham
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males, aged 18 to 35 years, and BMI 19 \- 28
- •2\.No chronic oral or nasal symptoms
- •3\.Provision of and capacity to give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Participation in healthy volunteer study within last 3 months
- •2\.Tobacco use within the last 2 years
- •3\.Alcohol or substance abuse within the last 5 years
- •4\.Recent history of prescription or OTC medication use
- •5\.Major surgery within the last 6 months
- •6\.Subjects with renal or hepatic impairment
- •7\.Subjects with cardiac disease
- •8\.Subjects with any GI inflammatory disease
- •9\.Diabetics
- •10\.Allergies to any of the components of the product (listed in SmPC)
Outcomes
Primary Outcomes
Not specified
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