Conditions: Healthy
Keywords: bioavailability pharmacokinetics healthy crossover trazodone
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Detailed description:
The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Blood samples will be collected predose and at pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the ratio of least-squares means and/or 90% confidence interval criteria.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl
Intervention descriptions: intervention 1: 100 mg immediate-release tablet, dosing q8h intervention 2: 300 mg extended-release caplet, single dose

Protocol document: