NCT06773767

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	150 mg trazodone hydrochloride	To compare the bioavailability of 150 mg trazodone hydrochloride tablets (new polymer) vs. 150 mg trazodone hydrochloride Contramid® tablets at steady-state.
DRUG	300 mg trazodone hydrochloride	To compare the bioavailability of 300 mg trazodone hydrochloride tablets (new polymer) vs. 300 mg trazodone hydrochloride Contramid® tablets at steady-state

Timeline

• Start date: 2024-05-22
• Primary completion: 2024-08-07
• Completion: 2024-08-07
• First posted: 2025-01-14
• Last updated: 2025-09-03

Locations

1 site across 1 country: Germany