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New trazodone formula tested for similarity to current version

NCT ID NCT06773767

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a new polymer version of the antidepressant trazodone (150 mg and 300 mg tablets) is absorbed in the body the same way as the current Contramid® version. Sixty-four healthy adults took both forms in a crossover design to measure drug levels in the blood. The goal was to see if the new version is bioequivalent, meaning it could be used as an alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trazodone hydrochloride
What this could lead to
If successful, this could show that the new polymer version of trazodone works just as well as the current one, potentially offering a more affordable or easier-to-manufacture option.
What could go wrong
This is an early-stage study in healthy volunteers, not patients. It only checks how the drug is absorbed, not if it works better or has fewer side effects. The results may not apply to people with depression or anxiety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

May 2024

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • SocraTec R&D GmbH Clinical Pharmacology

    Erfurt, Germany, 99084, Germany

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