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Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions

Healthy Clinical Trial

Official title:
A Randomized, Two-way Cross-over Comparative Bioavailability Study of 300 mg Trazodone Hydrochloride Containing New Polymer vs. 300 mg Trazodone Hydrochloride Containing Contramid® Prolonged-release Tablets Under Fasting Conditions

Clinical Trial Summary

This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.

Clinical Trial Description

A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting. To investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05136521
Study type Interventional
Source Aziende Chimiche Riunite Angelini Francesco S.p.A
Contact
Status Completed
Phase Phase 1
Start date February 17, 2020
Completion date July 19, 2020
View Details
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