A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Healthy SubjectsBioavailabilityPharmacokinetics
Interventions
DRUG

Trazodone HCl

"Dosage form:~Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study).~Dose regimen:~75 mg trazodone HCl (½ x 150 mg extended-release caplet) on Days 1 and 11, 150 mg trazodone HCl (one extended-release caplet) on Days 2 and 10, 300 mg trazodone HCl (one extended-release caplet) on Days 3 to 9, each at 23:30 after a fast of at least 4 hours."

DRUG

Trazodone HCl

"Dosage form:~Immediate-release tablet containing 100 mg trazodone HCl~Dose regimen:~100 mg trazodone HCl (one immediate-release tablet) once (at 23:30) on Days 1 and 11, 100 mg trazodone HCl (one immediate-release tablet) twice (at 23:30 and 11:30) on Days 2 and 10, 100 mg trazodone HCl (one immediate-release tablet) three times daily (at 23:30, 07:30 and 15:30) on Days 3 to 9. Evening doses were administered after a fast of at least 4 hours."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Labopharm Inc.

INDUSTRY

NCT01121926 - A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State | Biotech Hunter | Biotech Hunter