NCT02785601

PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese

Pharmacokinetics Study of Trazodone Hydrochloride Prolonged -Released Tablets in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.

Detailed description

Trial I single dose (75mg and 150mg), fasting or postprandial comparative pharmacokinetics of trazodone hydrochloride prolonged-release tablets and ordinary formulation; 16 patients (males and females, half and half). Trial is a 4-period, 4 cross (4x4) Williams crossover design, screened 16 subjects (half males and half females) were randomly divided into four groups (I-1, I-2, I-3, I-4), each 2 men and 2 women, give the following four different crossover treatments: (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) Time for drug administration is around 8:00am. Wash-out period is 7 days. Blood sampling will be performed before (0h) and after administration each dose group 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0h. Trial I. 4X4 Williams design Group Period 1 Period 2 Period 3 Period 4 I-1 A D B C I-2 B A C D I-3 C B D A I-4 D C A B

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Trazodone Hydrochloride prolonged-release tablets	strength 75mg, 150 mg. Oral administration with 200ml water

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-11-30
• Completion: 2018-01-04
• First posted: 2016-05-30
• Last updated: 2018-09-05

Locations

1 site across 1 country: Hong Kong