NCT05136521

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trazodone HCl - new polymer	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.
DRUG	Trazodone HCl - Contramid®	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.

Timeline

• Start date: 2020-02-17
• Primary completion: 2020-07-19
• Completion: 2020-07-19
• First posted: 2021-11-29
• Last updated: 2021-11-29

Locations

1 site across 1 country: Switzerland