A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects|
- Pharmacokinetics as evaluated from blood concentrations of duloxetine [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Serum BDNF level as evaluated from blood sample [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: low dose group
single oral administer 15mg duloxetine
15mg, oral administer
Other Name: generic duloxetine
Experimental: moderate dose group/multiple dose group
single oral duloxetine 30mg, after that repeat 7 oral duloxetine 30mg/d
30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days
Other Name: Generic duloxetine
Experimental: high dose group/crossover group
single oral duloxetine 60mg, after that single oral innovator duloxetine 60mg
60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine
Other Name: generic duloxetine; innovator duloxetine
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 concentration)and 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.
|Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 200030|
|Principal Investigator:||Huafang LI, MD, PhD||Drug Clinical Trial Office, Shanghai Mental Health Center|