Bioavailability Heathy VolunteersPhase 1NCT06773767
Bioavailability of Trazodone Hydrochloride (New Polymer) vs. Trazodone Hydrochloride Contramid® at Steady-state.
A Phase 1 study testing 150 mg trazodone hydrochloride and 300 mg trazodone hydrochloride in people with Bioavailability Heathy Volunteers and Bioavailability Study, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Heathy Volunteers, Bioavailability Study, Bioequivalance
- What is being tested?
- 150 mg trazodone hydrochloride and 300 mg trazodone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 22 May 2024to 7 Aug 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Two-way, Crossover, Two Parallel Groups Study to Compare the Bioavailability of 150 mg and 300 mg Trazodone Hydrochloride Tables (New Polymer) vs. 150 mg and 300 mg Trazodone Hydrochloride Contramid® Tables at Steady-state.
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.
- Being tested
- 150 mg trazodone hydrochloride, 300 mg trazodone hydrochloride
- Keywords
- Bioavailability, Oral multiple dose, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 mg trazodone hydrochlorideDrug
To compare the bioavailability of 150 mg trazodone hydrochloride tablets (new polymer) vs. 150 mg trazodone hydrochloride Contramid® tablets at steady-state.
300 mg trazodone hydrochlorideDrug
To compare the bioavailability of 300 mg trazodone hydrochloride tablets (new polymer) vs. 300 mg trazodone hydrochloride Contramid® tablets at steady-state
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 150 mg | Experimental | Treatment with two differet formulations of 150 mg trazodone hydrochloride during treatment period Receives: Drug: 150 mg trazodone hydrochloride |
| Group 2: 300 mg | Experimental | Treatment with two different formulations of 300 mg trazodone hydrochloride during treatment period Receives: Drug: 300 mg trazodone hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 150 mg
Assessment of bioequivalence of Test 1 in comparison to Reference 1 after multiple dose administration under fasting conditions determined by means of the AUC(0-Tau),ss, of trazodone.
Measured: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 150 mg
Assessment of bioequivalence of Test 1 in comparison to Reference 1 after multiple dose administration under fasting conditions determined by means of the CTau, ss of trazodone.
Measured: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 150 mg
Assessment of bioequivalence of Test 1 in comparison to Reference 1 after multiple dose administration under fasting conditions determined by means of the Cmax,ss of trazodone.
Measured: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 300 mg
Assessment of bioequivalence of Test 2 in comparison to Reference 2 after multiple dose administration under fasting conditions determined by means of the AUC(0-Tau),ss of trazodone
Measured: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 300 mg
Assessment of bioequivalence of Test 2 in comparison to Reference 2 after multiple dose administration under fasting conditions determined by means of the CTau,ss of trazodone
Measured: 5 days
Assessment of bioequivalence of two different formulations of trazodone hydrochloride tablets 300 mg
Assessment of bioequivalence of Test 2 in comparison to Reference 2 after multiple dose administration under fasting conditions determined by means of the Cmax,ss of trazodone
Measured: 5 days
Secondary outcomes (7)
Comparison of pharmacokinetic profiles (Concentration) of Test and Reference products
Concentration at the end of the dosing interval after the 1st, 2nd, 3rd and 4th IMP administration during treatment phase, considering scheduled times
Measured: 5 days
Comparison of pharmacokinetic profiles (Cmin, ss) of Test and Reference products
Observed (absolute) minimum concentrations within the dosing interval Tau (profile day), considering scheduled times
Measured: 5 days
Comparison of pharmacokinetic profiles (Fluctuation%) of Test and Reference products
Fluctuation as peak trough fluctuation, fluctuation% = {[Cmax,ss - Cmin,ss]/Cav} •100%
Measured: 5 days
Comparison of pharmacokinetic profiles (Cav)of Test and Reference products
Average concentration at steady-state, Cav = AUC(0-Tau),ss/Tau
Measured: 5 days
Comparison of pharmacokinetic profiles (Tmax, ss))of Test and Reference products
Time to reach the maximum concentration within each dosing interval (profile day), obtained directly from the data
Measured: 5 days
Descriptive characterisation of safety of Test and Reference products
Descriptive characterisation of safety of Test and Reference products considering adverse events observed during the trial
Measured: 8 days
Descriptive characterisation of tolerability of Test and Reference products
Descriptive characterisation of tolerability of Test and Reference products considering adverse events observed during the trial
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start22 May 2024
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability Heathy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To compare the bioavailability of 150 mg and 300 mg trazodone hydrochloride tablets (new polymer) vs. 150 mg and 300 mg trazodone hydrochloride Contramid® tablets at steady-state.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773767
- Sponsor's protocol ID
- 039(Ca)MD23341
- Other IDs
- 2024-511612-24-00
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No