28
Participants
Start Date
February 17, 2020
Primary Completion Date
July 19, 2020
Study Completion Date
July 19, 2020
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.
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.
CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:, Arzo
Collaborators (1)
Cross Research S.A.
INDUSTRY
Aziende Chimiche Riunite Angelini Francesco S.p.A
INDUSTRY