Ignite Creation Date:
2024-05-05 @ 9:39 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00933452
Status:
COMPLETED
Last Update Posted:
2010-06-15
First Post:
2009-07-05
Brief Title:
A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2010-06
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 primary objective of this study is to evaluate the pharmacokinetics of duloxetine hydrochloride tablets in Chinese Han Healthy Subjects The single oral dose and multiple oral dose of the drug in the body and the effects of different dosages of the drug will also be evaluated
Detailed Description:
This is an open parallel assignment low-dose moderate-dose and high-dose inpatient sequential-group pharmacokinetics study of single oral administered and multiple oral administered to healthy Chinese male and female subjects at a single investigational site All subjects are from the Chinese Han race
Approximately 36 healthy male and female Chinese subjects will participate in this study One half of the subjects enrolled in each dose group will be female Twelve subjects will be enrolled in each of 3 dose level groups
Safety will be evaluated from self-reported adverse events scheduled physical examination vital signs 12-lead ECGs and clinical laboratory test results
Single-dose blood samples 5 mL will be obtained within 2 hours before test article administration and at 1 2 3 4 5 6 8 12 15 24 36 48 and 72 hours after test article administration
Multiple-dose subjects of moderate dose group finished first step single-dose 30mg trial one week later will be repeatedly administered duloxetine 30 mg 7days blood samples 5 mL will be obtained at 4th 5th 6th and 7th day before test article administration to test the valley concentrationand at 1 2 3 4 5 6 8 12 15 24 36 48 and 72 hours after last test article administration 7th day
Cross-over subjects of high dose group finished first step single-dose 60 mg generic duloxetine trial one week later will be administered single-dose innovator duloxetine 60 mg blood samples will be obtained as same as first step
Approximately 36 healthy male and female Chinese subjects will participate in this study One half of the subjects enrolled in each dose group will be female Twelve subjects will be enrolled in each of 3 dose level groups
Safety will be evaluated from self-reported adverse events scheduled physical examination vital signs 12-lead ECGs and clinical laboratory test results
Single-dose blood samples 5 mL will be obtained within 2 hours before test article administration and at 1 2 3 4 5 6 8 12 15 24 36 48 and 72 hours after test article administration
Multiple-dose subjects of moderate dose group finished first step single-dose 30mg trial one week later will be repeatedly administered duloxetine 30 mg 7days blood samples 5 mL will be obtained at 4th 5th 6th and 7th day before test article administration to test the valley concentrationand at 1 2 3 4 5 6 8 12 15 24 36 48 and 72 hours after last test article administration 7th day
Cross-over subjects of high dose group finished first step single-dose 60 mg generic duloxetine trial one week later will be administered single-dose innovator duloxetine 60 mg blood samples will be obtained as same as first step
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SMHC-106 | None | None | None |