Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02785601
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2016-05-24
Brief Title:
PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese
Sponsor:
Lees Pharmaceutical Limited
Organization:
Lees Pharmaceutical Limited
Study Overview
Official Title:
Pharmacokinetics Study of Trazodone Hydrochloride Prolonged -Released Tablets in Chinese Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 800am Wash-out period is 7 days Blood sampling will be performed before 0h and after administration each dose group 05 10 20 30 40 50 60 80 100 120 160 240 360 480 720h
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
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 800am Wash-out period is 7 days Blood sampling will be performed before 0h and after administration each dose group 05 10 20 30 40 50 60 80 100 120 160 240 360 480 720h
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None