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

NCT00933452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-06-15

No results posted yet for this study

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

Interventions

DRUG

duloxetine

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

DRUG

duloxetine

15mg, oral administer

DRUG

duloxetine

60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine

Sponsors & Collaborators

  • Jiangsu Nhwa Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Huafang LI, MD, PhD · Drug Clinical Trial Office, Shanghai Mental Health Center

Study Design

Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933452 on ClinicalTrials.gov