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

NCT ID: NCT00933452

Last Updated: 2010-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Healthy

Study Design

• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

low dose group

single oral administer 15mg duloxetine

Group Type: EXPERIMENTAL

duloxetine

Intervention Type: DRUG

15mg, oral administer

moderate dose group/multiple dose group

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

Group Type: EXPERIMENTAL

duloxetine

Intervention Type: DRUG

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

high dose group/crossover group

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

Group Type: EXPERIMENTAL

duloxetine

Intervention Type: DRUG

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

Interventions

duloxetine

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

Intervention Type: DRUG

duloxetine

15mg, oral administer

Intervention Type: DRUG

duloxetine

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

Intervention Type: DRUG

Other Intervention Names

Generic duloxetine; generic duloxetine; generic duloxetine; innovator duloxetine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Nhwa Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Shanghai Mental Health Center

Principal Investigators

Huafang LI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Drug Clinical Trial Office, Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SMHC-106

Identifier Type: -

Identifier Source: secondary_id

2006L01603

Identifier Type: -

Identifier Source: org_study_id