Who is sponsoring NCT01121926?

NCT01121926 is sponsored by Labopharm Inc..

What condition does NCT01121926 study?

NCT01121926 studies Healthy Subjects, Bioavailability, Pharmacokinetics.

What drugs are being tested in NCT01121926?

Interventions: Trazodone HCl, Trazodone HCl.

What is the status of NCT01121926?

NCT01121926 is currently COMPLETED.

Last reviewed 2012-04-25 · How we verify

A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered Once Daily) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) at Steady State

NCT01121926 Phase 1 COMPLETED Results posted

The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.

Details

Lead sponsor	Labopharm Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2008-01
Completion	2008-03

Conditions

Healthy Subjects
Bioavailability
Pharmacokinetics

Interventions

Trazodone HCl
Trazodone HCl

Primary outcomes

Bioequivalence Based on Cmax,ss — 9 days
Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).
Bioequivalence Based on AUCss — 9 days
AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss. Measured in nanograms x hours per milliliter (ng\*h/mL).