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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001575-30-GB
Enrollment
12
Registered
2008-07-25
Start date
2008-08-18
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status epilepticus MedDRA version: 9.1 Level: LLT Classification code 10041962 Term: Status epilepticus

Interventions

Trade Name: Ativan Product Name: Lorazepam Pharmaceutical Form: Injection* INN or Proposed INN: LORAZEPAM CAS Number: 846491 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026