Status and phase
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About
The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Any of the abnormalities of ECGs examination occurs in screening period or the first day of administration:
Life style:
Others:
The female subjects are not eligible for inclusion in this study if she meet any of the following criteria above and below:
Primary purpose
Allocation
Interventional model
Masking
15 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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