INTERVENTION: Each subject will receive a single oral dose of IBSA Lorazepam 2.5 mg orodispersible film and Tavor® 2.5 mg film‐coated tablets under fasting conditions, in two study periods, with a wash‐out interval of at least 7 days between the two administrations, according to a 2‐way cross‐over randomised design. The investigational medicinal products will be orally administered on Day 1 of each study period at 08:00±1h as follows: ‐ one orodispersible film of IBSA Lorazepam 2.5 mg without water ‐ one film‐coated tablet of Tavor® 2.5 mg with 150 mL of still mineral water Just before the administration of IBSA Lorazepam 2.5 mg orodispersible film, the Investigator or deputy will take the orodispersible film out of the packaging. To avoid its inadvertent breakage, the Investigator or deputy shall: 1. take the envelope and hold it with the side not sealed facing up 2. gently peel both parts of the envelope and then hold each between his/her thumb and inde Xfingers using one hand for each part 3. carefully tear both parts of the envelope in opposite directions until they will be separated. The film will be visible and placed on one of the separated envelope parts. The Investigator or deputy will place the film directly on the subject's tongue. The Investigator will wear gloves during the administration procedure. The film will dissolve rapidly. Subjects will let the orodispersible film completely dissolve in their mouth. It must not be swallowed whole and must not be chewed or broken. The subject will be allowed to swallow saliva as the film dissolves in the mouth. In detail, once the subject feels that the film has completely dissolved, he/she will inform the Investigator who will inspect the subject’s mouth and verify the complete dissolution in the mouth. If the subject does n CONDITION: Lorazepam will be administered to healthy volunteers ; Not Applicable PRIMARY OUTCOME: Rate (Cmax) and extent (AUC0‐t) of lorazepam absorption in plasma measured from plasma samples taken at pre‐dose (0) and at 0.5 (30 min), 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 h post‐dose after single dose administration of IBSA Lorazepam 2.5 mg orodispersible film and Tavor® 2.5 mg film‐coated tablets under fasting conditions. SECONDARY OUTCOME: 1. Time to peak (Tmax), relative bioavailability (Frel) and, if feasible, area under the concentration‐time curve extrapolated to infinity (AUC0‐inf), percentage of the residual area extrapolated to infinity in relation to the total AUC0‐inf (%AUCextra), half‐life (t1/2) and terminal elimination rate constant (?Z) of plasma lorazepam measured from plasma samples taken at pre‐dose (0) and at 0.5 (30 min), 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 h post‐dose after single‐dose administration of IBSA Lorazepam 2.5 mg orodispersible film and Tavor® 2.5 mg film‐coated tablets under fasting conditions; 2. All adverse events occurring after the informed consent signature but before the first dose of the investigational medicinal product (PTAEs), all adverse events occurring or worsening after the first dose of the investigational medicinal product (TEAEs), vital signs (blood pressure and heart rate, measured at the screening visit, on Day ‐1 of each study period, on Days 1‐4 of each study period at pre‐dose (0), 1.5, 3, 24, 48 and 72 h post‐dose and at early termination visit [ETV] as applicable), body weight (measured at screening and final visit/ETV as applicable), physical examinations (performed at screening and final visit/ETV as applicable), clinical laboratory parameters (haematology, blood chemistry and urine analysis performed at screening and final visit/ETV as applicable; virology performed at screening; urine drug screening test and alcohol saliva test performed at screening and on Day ‐1 of each study period; a COVID‐19 rapid test performed on Day ‐1 of each study period; serum pregnancy test performed at screening; urine pregnancy test on Day ‐1 of each study period), ECG (performed at screening and final visit/ETV as applicable).; INCLUSION CRITERIA: 1. Informed consent: signed written informed consent before inclusion in the study 2. Se Xand Age: men and women, 18‐55 years old inclusive 3. Body Mass Index: 18.5‐30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100‐139 mmHg, diastolic blood pressure 50‐89 mmHg, heart rate 50‐99 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator and to comply with the requirements of the entire study 6. Contraception and fertility (women only): women of child‐bearing potential must be using at least one of the following reliable methods of contraception: 6.1. A non‐hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
Epistemonikos ID: 0ad794007d9ffa941ac407ae5a28e2d9767fbc53
First added on: May 25, 2024
