A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Jiangsu Nhwa Pharmaceutical Co.,LTD
Information provided by:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT00933452
First received: July 5, 2009
Last updated: June 11, 2010
Last verified: June 2010
  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 1

Study Type: Interventional
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

Resource links provided by NLM:


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
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low dose group
single oral administer 15mg duloxetine
Drug: 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
Drug: duloxetine
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
Drug: duloxetine
60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine
Other Name: generic duloxetine; 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
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: LI, Huafang, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT00933452     History of Changes
Other Study ID Numbers: 2006L01603, SMHC-106
Study First Received: July 5, 2009
Last Updated: June 11, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Mental Health Center:
duloxetine
pharmacokinetics
antidepressant
antidepressive agents
depression
psychotropic drugs
safety
Chinese
HAN
BDNF

Additional relevant MeSH terms:
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 30, 2014