Conditions: Healthy
Keywords: Healthy subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: yes

Brief summary:
The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.

Detailed description:

Arms:
arm 1: OAD: Once A Day arm 2: None

Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl
Intervention descriptions: intervention 1: Dosage form: Extended-release caplets containing 300 mg trazodone HCl

Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours. intervention 2: Dosage form: Immediate-release tablets containing 100 mg trazodone HCl

Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.

Protocol document: