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

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

July 19, 2020

Study Completion Date

July 19, 2020

Conditions
Healthy
Interventions
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.

Trial Locations (1)

CH-6864

CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:, Arzo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cross Research S.A.

INDUSTRY

lead

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY