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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00933452 |
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Date of registration:
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05/07/2009 |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects
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Scientific title:
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A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00933452 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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China
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Contacts
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Name:
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Huafang LI, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Drug Clinical Trial Office, Shanghai Mental Health Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: duloxetine
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Primary Outcome(s)
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Pharmacokinetics as evaluated from blood concentrations of duloxetine
[Time Frame: 2 months]
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Secondary Outcome(s)
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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]
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Serum BDNF level as evaluated from blood sample
[Time Frame: 2 months]
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Secondary ID(s)
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2006L01603
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SMHC-106
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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