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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborator: Jiangsu Nhwa Pharmaceutical Co., Ltd.
• Treatments: Duloxetine Hydrochloride

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