Depression Clinical Trial
Official title:
Pharmacokinetics Study of Trazodone Hydrochloride Prolonged -Released Tablets in Chinese Healthy Volunteers
The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.
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
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