A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects - Full Text View

Sponsors and Collaborators:	Shanghai Mental Health Center Jiangsu Nhwa Pharmaceutical Co.,LTD
Information provided by:	Shanghai Mental Health Center
ClinicalTrials.gov Identifier:	NCT00933452

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: duloxetine	Phase I

Study Type:	Interventional
Study Design:	Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Open Single-Dose and Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:

Pharmacokinetics as evaluated from blood concentrations of duloxetine [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	36
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
low dose group: Experimental single oral administer 15mg duloxetine	Drug: duloxetine 15mg, oral administer
moderate dose group/multiple dose group: Experimental single oral duloxetine 30mg, after that repeat 7 oral duloxetine 30mg/d	Drug: duloxetine 30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days
high dose group/crossover group: Experimental single oral duloxetine 60mg, after that single oral innovator duloxetine 60mg	Drug: duloxetine 60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Chinese Han male or female determined by the investigator on the basis of medical history and physical examination
Age from 18 to 45 years old at screening
Body mass index (BMI) from 19~24 kg/m2 and body weight ≥ 50 kg at screening
Normal clinical laboratory test results or 'no clinical significantly abnormal' results judged by the investigator at screening
Subjects can comply with all requirements of the study according to study procedure
A sighed and dated ICF (informed consent form) with approval by IEC

Exclusion Criteria:

Participation in any drug trial within 1 month prior to enrollment into this study
Known hypersensitivity to duloxetine hydrochloride or relative compounds
Abnormal 12-lead electrocardiogram (ECG) results and increasing risk to participate this study determined by investigator
Presence or history of any medical disorder, including cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, psychiatric and neurologic system, or medical conditions that would significantly affect the absorption, distribution, metabolism, or excretion of investigational drug, or increase risk to administer investigational drug, or interfere explanation for data
History of hepatitis B and/or HBsAg (+)
Serum HIV antibody (+) or hepatitis C Antibody (+)
Female subjects of childbearing potential with a positive human chorionic gonadotropin (HCG) test or lack of a reliable method of contraception
History of blood donor within 3 months prior to enrollment
History of drug abuse or alcoholism
Use any drugs including traditional Chinese Medicine within 1 week prior to enrollment
Any unsuitable subjects judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933452

Contacts

Contact: Huafang LI, MD, PhD	86-21-64387250 ext 3128	lhlh5@yahoo.com.cn
Contact: Yan LI, MD	86-21-64387250 ext 3122	liyan7721@yeah.net

Locations

China
Shanghai Mental Health Center	Recruiting
Shanghai, China, 200030
Contact: Huafang LI, MD,PhD 86-21-64387250 ext 3128 lhlh5@yahoo.com.cn
Contact: Yan LI, MD 86-21-64387250 ext 3122 liyan7721@yeah.net
Principal Investigator: Huafang LI, MD,PhD
Sub-Investigator: Yan LI, MD
Sub-Investigator: Yimin YU, MD
Sub-Investigator: Yifeng SHEN, MD

Sponsors and Collaborators

Shanghai Mental Health Center

Jiangsu Nhwa Pharmaceutical Co.,LTD

Investigators

Principal Investigator:

Huafang LI, MD, PhD

Drug Clinical Trial Office, Shanghai Mental Health Center

More Information

No publications provided

Responsible Party:	Shanghai Mental Health Center ( LI, Huafang )
Study ID Numbers:	2006L01603, SMHC-106
Study First Received:	July 5, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00933452 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shanghai Mental Health Center:

duloxetine
pharmacokinetics
antidepressant
antidepressive agents
depression

psychotropic drugs
safety
Chinese
HAN
BDNF

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Healthy
Depressive Disorder

Serotonin Uptake Inhibitors
Duloxetine
Serotonin
Dopamine
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 10, 2009