Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

A Phase 1 study of Depressive Disorder, run by GlaxoSmithKline at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile Read more about this study

Who is it for?: Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Disorder
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 24 Mar 2006to 26 Apr 2006
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 19 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

19-45 years healthy Chinese
Body weight > 50 kg
BMI between 19-25
serological negative for HIV, syphilis and hepatitis B and C
no abnormalities in ECG
Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Who cannot join

History of chronic physical/mental disease, current disease and concomitant medication

Trial locations and contacts

1 site in 1 country.

China1 site

GSK Investigational Site
Beijing, 100730

Other trials in China

About this study

Official title: A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects

Conditions: Depressive Disorder
Being tested: Paroxetine controlled release tablet
Keywords: BRL029060/Paroxetine CR, pharmacokinetics, safety
Medical subject headings: Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paroxetine controlled release tabletDrug
Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.

Study groups in NCT00406003
Study group	Role	What they receive
Subjects receiving treatment sequence ABC	Experimental	Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days. Receives: Drug: Paroxetine controlled release tablet
Subjects receiving treatment sequence BAC	Experimental	Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days. Receives: Drug: Paroxetine controlled release tablet
Subjects receiving treatment sequence CBA	Experimental	Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days. Receives: Drug: Paroxetine controlled release tablet
Subjects receiving treatment sequence BCA	Experimental	Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days. Receives: Drug: Paroxetine controlled release tablet
Subjects receiving treatment sequence CAB	Experimental	Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days. Receives: Drug: Paroxetine controlled release tablet
Subjects receiving treatment sequence ACB	Experimental	Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days. Receives: Drug: Paroxetine controlled release tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects
Measured: Up to 32 days

Secondary outcomes (1)

To describe Safety profile of healthy subjects when dosed with paroxetine controlled release
Measured: Up to 32 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 200626 Apr 2006

First posted4 Dec 2006 (estimated)
Study start24 Mar 2006
Primary completion26 Apr 2006
Study completion26 Apr 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00406003
Sponsor's protocol ID: PCR104074
Status last verified: Sep 2017
First submitted: 30 Nov 2006
Last updated: 29 Sep 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT00406003
Acronym / sponsor ID: PCR104074
Conditions: Depressive Disorder
Keywords: BRL029060/Paroxetine CR, pharmacokinetics, safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 24 Mar 2006 (actual)
Primary completion: 26 Apr 2006 (actual)
Study completion: 26 Apr 2006 (actual)
First posted: 4 Dec 2006 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Subjects receiving treatment sequence ABC	Experimental	Drug: Paroxetine controlled release tabletEligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence BAC	Experimental	Drug: Paroxetine controlled release tabletEligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence CBA	Experimental	Drug: Paroxetine controlled release tabletEligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence BCA	Experimental	Drug: Paroxetine controlled release tabletEligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence CAB	Experimental	Drug: Paroxetine controlled release tabletEligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.
Subjects receiving treatment sequence ACB	Experimental	Drug: Paroxetine controlled release tabletEligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Who may qualify

Ages: 19 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

19-45 years healthy Chinese
Body weight > 50 kg
BMI between 19-25
serological negative for HIV, syphilis and hepatitis B and C
no abnormalities in ECG

Key exclusion criteria (1 listed)

History of chronic physical/mental disease, current disease and concomitant medication

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
Paroxetine controlled release tabletParoxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.	Drug	Subjects receiving treatment sequence ABC, Subjects receiving treatment sequence ACB, Subjects receiving treatment sequence BAC, Subjects receiving treatment sequence BCA, Subjects receiving treatment sequence CAB, Subjects receiving treatment sequence CBA

Primary outcome

To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects
Time frame: Up to 32 days

1 secondary outcome

To describe Safety profile of healthy subjects when dosed with paroxetine controlled release
Time frame: Up to 32 days

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 29 Sep 2017.
Results for study PCR104074 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

Related trials for Depressive Disorder

Recruiting
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Not yet recruiting
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Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
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Superior Semicircular Canal Dehiscence
Recruiting
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Recruiting
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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.

GSK Clinical Trials study director

GlaxoSmithKline

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 of Depressive Disorder, run by GlaxoSmithKline 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 1 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 29 Sep 2017. 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?

To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects (time frame: Up to 32 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00406003.

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 29 Sep 2017.