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

NCT00933452 | Completed Phase 1 DMC

• 2 other identifiers: 2006L01603SMHC-106
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

duloxetine; pharmacokinetics; antidepressant; antidepressive agents; depression; psychotropic drugs; safety; Chinese; HAN; BDNF

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics as evaluated from blood concentrations of duloxetine

  2 months

Secondary Outcomes (2)

• 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

  2 months

• Serum BDNF level as evaluated from blood sample

  2 months

Study Arms (3)

low dose group

EXPERIMENTAL

single oral administer 15mg duloxetine

Drug: duloxetine

moderate dose group/multiple dose group

EXPERIMENTAL

single oral duloxetine 30mg, after that repeat 7 oral duloxetine 30mg/d

Drug: duloxetine

high dose group/crossover group

EXPERIMENTAL

single oral duloxetine 60mg, after that single oral innovator duloxetine 60mg

Drug: duloxetine

Interventions

duloxetine DRUG

30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days

Also known as: Generic duloxetine

moderate dose group/multiple dose group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Jiangsu Nhwa Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huafang LI, MD, PhD

  Drug Clinical Trial Office, Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

CN (1)