E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041962 |
E.1.2 | Term | Status epilepticus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To compare these pharmacokinetic parameters of lorazepam when administered by the buccal and intranasal routes and estimate their equivalence. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be defined as the final visit of the last participant |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |