Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02785614
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2016-05-24
Brief Title:
PK Study of Multi-dose 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 evaluate the pharmacokinetics comparative studies in a single dose multiple dose
Detailed Description:
Trial II Multiple dose the highest specification 150mg pharmacokinetic study of Trazodone Hydrochloride Prolonged Release Tablets 12 patients males and females half and half
2-period 2 cross 2x2 crossover design was used screened 12 subjects males and females were randomly divided into two groups II-1II-2 each 3 males and 3 females give the following two different crossover treatments trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days in T group trazodone hydrochloride tablets 50mg for 3 times per day for 7 days in R group Wash-out period is 14 days
Trial II 2X2 design Group Period 1 Period 2 II -1 R T II -2 T R T group the subjects will be provided trazodone hydrochloride prolonged-release tablet 150mg at about800am each day Sampling site will be conducted in day 1 5 6 7 before administration in this period blood sampling will be conducted in 05 10 20 30 40 50 60 80 100 120 160 240 360 480 720h after administration on day 7
R group The subjects will receive 50mg trazodone hydrochloride tablet 50mg for 3 times after receiving standard light breakfast at 600am standard meal at 1400 and 2200 Blood sampling will be conducted on day 1 5 6 7 before first administration in this period blood sampling will be conducted at 05 10 15 20 30 40 60 80 before the second time administration 85 90 95 100 110 120 140 160 before the third time administration 165 170 175 180 190 200 220 240 360 480 720h after administration on day 7
50 mL venous blood from forearm venous blood was took through venous indwelling needle and transfer into the heparin tube After plasma separation it stored in low temperature in a refrigerator
2-period 2 cross 2x2 crossover design was used screened 12 subjects males and females were randomly divided into two groups II-1II-2 each 3 males and 3 females give the following two different crossover treatments trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days in T group trazodone hydrochloride tablets 50mg for 3 times per day for 7 days in R group Wash-out period is 14 days
Trial II 2X2 design Group Period 1 Period 2 II -1 R T II -2 T R T group the subjects will be provided trazodone hydrochloride prolonged-release tablet 150mg at about800am each day Sampling site will be conducted in day 1 5 6 7 before administration in this period blood sampling will be conducted in 05 10 20 30 40 50 60 80 100 120 160 240 360 480 720h after administration on day 7
R group The subjects will receive 50mg trazodone hydrochloride tablet 50mg for 3 times after receiving standard light breakfast at 600am standard meal at 1400 and 2200 Blood sampling will be conducted on day 1 5 6 7 before first administration in this period blood sampling will be conducted at 05 10 15 20 30 40 60 80 before the second time administration 85 90 95 100 110 120 140 160 before the third time administration 165 170 175 180 190 200 220 240 360 480 720h after administration on day 7
50 mL venous blood from forearm venous blood was took through venous indwelling needle and transfer into the heparin tube After plasma separation it stored in low temperature in a refrigerator
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