Conditions: Healthy
Keywords: Healthy subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
The objectives of this study were:

* to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition;
* to assess the controlled release properties of the two prototype formulations;
* to select a prototype formulation for further development;
* to validate the blood sampling schedule for future pivotal pharmacokinetic studies;
* to determine the appropriate sample size for pivotal studies based in the intra-subject variability.

Detailed description:

Arms:
arm 1: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 2: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 3: None arm 4: None

Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl intervention 3: Trazodone HCl intervention 4: Trazodone HCl
Intervention descriptions: intervention 1: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 2: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 3: The dosage of trazodone.HCl during this treatment phase was 2 oral doses of 150 mg each: one controlled-release (CR) tablet at 07:30 (after an overnight fast of at least 10 hours) and 19:30 (after a fast of at least 2 hours) on clinic days. intervention 4: The dosage of trazodone.HCl during this treatment phase was three oral doses of 100 mg each: one immediate-release (IR) tablet at 07:30 (after an overnight fast of at least 10 hours), 15:30 and 23:30 (both dosages after a fast of at least 2 hours) on clinic days.

Protocol document: