HealthyPhase 1NCT00933452
A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects
A Phase 1 study testing duloxetine in people with Healthy, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 (+)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects
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.
Read the 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
- Being tested
- duloxetine
- Keywords
- duloxetine, pharmacokinetics, antidepressant, antidepressive agents, depression, psychotropic drugs, safety, Chinese, HAN, BDNF
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called Generic duloxetine
30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days
duloxetineDrug
Also called generic duloxetine
15mg, oral administer
duloxetineDrug
Also called generic duloxetine; innovator duloxetine
60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine
| Study group | Role | What they receive |
|---|---|---|
| low dose group | Experimental | single oral administer 15mg duloxetine Receives: Drug: duloxetine |
| moderate dose group/multiple dose group | Experimental | single oral duloxetine 30mg, after that repeat 7 oral duloxetine 30mg/d Receives: Drug: duloxetine |
| high dose group/crossover group | Experimental | single oral duloxetine 60mg, after that single oral innovator duloxetine 60mg Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics as evaluated from blood concentrations of duloxetine
Measured: 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
Measured: 2 months
Serum BDNF level as evaluated from blood sample
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Investigators
- Huafang LI, MD, PhD, Principal investigator, Drug Clinical Trial Office, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933452
- Sponsor's protocol ID
- 2006L01603
- Other IDs
- SMHC-106
- Status last verified
- Jun 2010
- First submitted
- 5 Jul 2009
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Safety of Duloxetine in Chinese Han Healthy Subjects
- ClinicalTrials.gov ID
- NCT00933452
- Acronym / sponsor ID
- 2006L01603
- Conditions
- Healthy
- Keywords
- duloxetine, pharmacokinetics, antidepressant, antidepressive agents, depression, psychotropic drugs, safety, Chinese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose group | Experimental | Drug: duloxetinesingle oral administer 15mg duloxetine |
| moderate dose group/multiple dose group | Experimental | Drug: duloxetinesingle oral duloxetine 30mg, after that repeat 7 oral duloxetine 30mg/d |
| high dose group/crossover group | Experimental | Drug: duloxetinesingle oral duloxetine 60mg, after that single oral innovator duloxetine 60mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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 (+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duloxetineAlso: Generic duloxetine30mg, oral administer; step 1: single dose; step 2: multiple dose, 7 days | Drug | moderate dose group/multiple dose group |
| duloxetineAlso: generic duloxetine15mg, oral administer | Drug | low dose group |
| duloxetineAlso: generic duloxetine; innovator duloxetine60mg, oral administer; step 1: generic duloxetine; step 2: Innovator duloxetine | Drug | high dose group/crossover group |
Primary outcome
Pharmacokinetics as evaluated from blood concentrations of duloxetine
Time frame: 2 months
2 secondary outcomes
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
Serum BDNF level as evaluated from blood sample
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang LI, MD, PhD principal investigator
Drug Clinical Trial Office, Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing duloxetine in people with Healthy, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics as evaluated from blood concentrations of duloxetine (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2010.