A study to assess the amount of active ingredient that reaches the blood circulation after administration in healthy men and women under fasting conditions of a new anxiolytic, sedative, and anticonvulsant mouth-dissolvable drug in comparison to the marketed tablets of Tavor®

Phase 1

Completed

• Conditions: orazepam will be administered to healthy volunteers; Not Applicable

• Registration Number: ISRCTN49118865
• Lead Sponsor: IBSA Institut Biochimique (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-03-08
• Study Start: 2024-05-24
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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 50-99 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
6.2. A male sexual partner who agrees to use a male condom with spermicide
6.3. A sterile sexual partner
or:
True abstinence (i.e., refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), lactational amenorrhea, and withdrawal are not acceptable.
Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, pregnancy test results must be negative at screening and Day -1.

Exclusion Criteria

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. SARS-CoV-2 test: positive Covid-19 rapid test at Day -1
11. Drug test: a positive result at the drug test at screening or Day -1
12. Alcohol test: positive alcohol saliva test at screening or Day -1
13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
14. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.