Lorazepam with antianxiety, sedative and anticonvulsant effects Not Applicable
Conditions
Interventions
For each subject, a single dose of Lorazepam IBSA 2.5 mg orodispersible film, a single dose of Tavor® 2.5 mg tablets and a single dose of Tavor® 2.5 mg orodispersible tablets will be administered unde
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and 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 50-90 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 co-operate 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: a. 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 b. A male sexual partner who agrees to use a male condom with spermicide c. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, pregnancy test result must be negative at screening and Day -1.
Exclusion criteria
Exclusion criteria: Subjects meeting any of these criteria will not be enrolled in the study: 1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; presence of mouth lesions or any other oral mucosa alteration; presence or history (within 28 days) of any tongue piercings; presence of any partials, braces or dentures 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principle or formulations' ingredients or both; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study 5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, immunological or neurological diseases that may interfere with the aim of the study 6. Medications: medications, including over the counter medications and herbal remedies for 2 weeks before the start of the study. Hormonal contraceptives for women will not be allowed 7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study 8. Blood donation: blood donations for 3 months before this study 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day) 10. Drug test: positive result at the drug test at screening 11. Alcohol test: positive alcohol breath test at Day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 13. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate (Cmax) and extent (AUC0-t and AUC0-inf, if feasible) of lorazepam absorption in plasma measured from plasma samples taken at pre-dose (0) and 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 administration of each of the three treatments (Lorazepam IBSA 2.5 mg orodispersible film, Tavor® 2.5 mg tablets and Tavor® 2.5 mg orodispersible tablets) under fasting conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to peak (tmax), relative bioavailability (Frel) and, if feasible, elimination half-life (t1/2) and terminal elimination rate constant (?z) of plasma lorazepam measured from plasma samples taken at pre-dose (0) and 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 administration of each of the three treatments (Lorazepam IBSA 2.5 mg orodispersible film, Tavor® 2.5 mg tablets and Tavor® 2.5 mg orodispersible tablets) under fasting conditions 2. All adverse events occurring after informed consent signature but before the first dose of investigational medicinal product (PTAEs), all adverse events occurring or worsening after the first dose of investigational medicinal product (TEAEs), vital signs (blood pressure and heart rate, measured at 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 test performed at screening; a serum pregnancy test at screening; urine pregnancy test at the entrance of each study period), ECG (performed at screening and final visit/ETV as applicable). | — |
Countries
Switzerland
Outcome results
None listed