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 Administratio

Conditions: Status epilepticus
MedDRA version: 9.1Level: LLTClassification code 10041962Term: Status epilepticus

Registration Number: EUCTR2008-001575-30-GB

Lead Sponsor: niversity of Nottingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 12

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)
11.Subjects with any medical condition that, in the opinion of the investigators, might impact on the outcome of the trial or the safety of the subject

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate pharmacokinetic parameters of lorazepam (AUC, Cmax, t½, tmax, CL/F and Vz/F) from the plasma concentration-time profile for intranasal and buccal administration routes in healthy adult volunteers.;Secondary Objective: To compare these pharmacokinetic parameters of lorazepam when administered by the buccal and intranasal routes and estimate their equivalence.;Primary end point(s): The primary endpoints are determination of the plasma concentration-time profiles of lorazepam when administered by the intranasal and buccal routes. The following parameters will be estimated from the observed concentration-time profiles: AUC, Cmax, t½, tmax, CL/F and Vz/F where possible.

Secondary Outcome Measures