Bioavailability of Trazodone Hydrochloride (New Polymer) vs. Trazodone Hydrochloride Contramid® at Steady-state.

NCT06773767 | Completed Phase 1

• 2 other identifiers: 039(Ca)MD233412024-511612-24-00
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability Heathy Volunteers; Bioavailability Study; Bioequivalance

Keywords

Bioavailability; Oral multiple dose; Bioequivalence

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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

  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

  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

  5 days

Secondary Outcomes (7)

• Comparison of pharmacokinetic profiles (Concentration) of Test and Reference products

  5 days

• Comparison of pharmacokinetic profiles (Cmin, ss) of Test and Reference products

  5 days

• Comparison of pharmacokinetic profiles (Fluctuation%) of Test and Reference products

  5 days

• Comparison of pharmacokinetic profiles (Cav)of Test and Reference products

  5 days

• Comparison of pharmacokinetic profiles (Tmax, ss))of Test and Reference products

  5 days

Study Arms (2)

Group 1: 150 mg

EXPERIMENTAL

Treatment with two differet formulations of 150 mg trazodone hydrochloride during treatment period

Drug: 150 mg trazodone hydrochloride

Group 2: 300 mg

EXPERIMENTAL

Treatment with two different formulations of 300 mg trazodone hydrochloride during treatment period

Drug: 300 mg trazodone hydrochloride

Interventions

150 mg trazodone hydrochloride DRUG

To compare the bioavailability of 150 mg trazodone hydrochloride tablets (new polymer) vs. 150 mg trazodone hydrochloride Contramid® tablets at steady-state.

Group 1: 150 mg

300 mg trazodone hydrochloride DRUG

To compare the bioavailability of 300 mg trazodone hydrochloride tablets (new polymer) vs. 300 mg trazodone hydrochloride Contramid® tablets at steady-state

Group 2: 300 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• SocraTec R&D GmbH: collaborator

Study Sites (1)

SocraTec R&D GmbH Clinical Pharmacology

Erfurt, Germany, 99084, Germany

Location

MeSH Terms

Interventions

Trazodone

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 14, 2025
• Study Start: May 22, 2024
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: September 3, 2025

Record last verified: 2024-10

Locations

DE (1)