Bioavailability of Trazodone Hydrochloride (New Polymer) Vs. Trazodone Hydrochloride Contramid® At Steady-state.

Angelini Pharma

Status and phase

Completed

Phase 1

Conditions

Bioavailability Study

Bioequivalance

Bioavailability Heathy Volunteers

Treatments

Drug: 150 mg trazodone hydrochloride

Drug: 300 mg trazodone hydrochloride

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06773767

2024-511612-24-00 (EU Trial (CTIS) Number)

039(Ca)MD23341

Details and patient eligibility

About

Two way, two parallel groups, crossover study to compare the bioavailability of 150 mg and 300 mg trazodone hydrochloride (new polymer) (Angelini Pharma S.p.A.) vs. 150 mg and 300 mg trazodone hydrochloride Contramid® (Angelini Pharma S.p.A.) at steady-state in 64 Healthy Volunteers.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Sex: male/female
Age: 18 to 65 years inclusive
Body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m²
Good state of health
Non-smoker or ex-smoker for at least 3 months
Written informed consent (including consent on personal data processing), after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Exclusion criteria

Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient.
Existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient.
Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient.
Presence or history of relevant and currently treated CNS and/or psychiatric disorders.
History of suicidal behaviour, suicidal intentions and/or suicidality among family members.
Nurses Global Assessment of Suicide Risk (NGASR)-scale showing a high or very high risk.
Known allergic reactions or hypersensitivity to the active ingredient used or to constituents of the pharmaceutical preparations
History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the Investigator
History of alcohol intoxication
History or known hyperthyroidism regardless of adequate treatment
History of or known micturition disorders
History of or known current increased intraocular pressure
Known hypotension, orthostatic syndrome or repeated occurrence of syncope
History of or current priapism
History of intoxication with drugs that attenuate the CNS or antihypertensives
Current treatment with opioids or serotonergic agents.
Systolic blood pressure < 90 or > 139 mmHg and diastolic blood pressure < 60 or > 89 mmHg Heart rate < 50 bpm or > 90 bpm
QTc interval > 450 ms for men and > 470 ms for women
Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the Investigator.
ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20% ULN and creatinine > 0.1 mg/dL ULN.
Positive anti-HIV-test, HBs-antigen-test, or anti-HCV-test
Vaccination against COVID-19 within the last 4 weeks prior to individual intended IMP administration
Acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
History of or current drug or alcohol dependence
Positive alcohol or drug test at screening examination
Regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day
Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
Regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
Blood donation or other blood loss of more than 400 ml within the last 6 months prior to individual enrolment of the subject
Participation in a clinical trial with administration of any investigational medicinal product during the last 6 months prior to individual enrolment of the subject
Simultaneous participation in another clinical trial with active ingredients
Regular treatment with any systemically available medication
Subjects, who report a frequent occurrence of migraine attacks
Positive pregnancy test at screening examination
Pregnant or lactating women
Female subjects who do not agree to apply highly effective contraceptive methods
Subject is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or has a close affiliation with the Sponsor or the investigational site; e.g., a close relative of the investigator, dependent person, employee of the Sponsor or affiliates
Subjects suspected or known not to follow instructions
Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial