Depressive DisorderPhase 1NCT00749359
PAXIL CR Bioequivalence Study
A Phase 1 study testing Paxil CR in people with Depressive Disorder, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Paxil CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2008to 16 Sep 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.
Who cannot join
- Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; >14 drinks/week for men or >7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Buffalo, New York, 14202
GSK Investigational Site
Tacoma, Washington, 98418
About this study
Official title: An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
- Conditions
- Depressive Disorder
- Being tested
- Paxil CR
- Keywords
- healthy volunteers, paroxetine
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxil CRDrug
Paxil CR 37mg tablet manufactures at two different sites
| Study group | Role | What they receive |
|---|---|---|
| open label treatment | Experimental | On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1. Receives: Drug: Paxil CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paroxetine blood levels
Measured: measured up to 168 hours after a single dose.
Secondary outcomes (1)
Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs
Measured: measured up to 168 hours after a single dose and throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study start7 Jul 2008
- Primary completion16 Sep 2008
- Study completion16 Sep 2008
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749359
- Sponsor's protocol ID
- PCR111656
- Status last verified
- Aug 2017
- First submitted
- 5 Sep 2008
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga
- ClinicalTrials.gov ID
- NCT00749359
- Acronym / sponsor ID
- PCR111656
- Conditions
- Depressive Disorder
- Keywords
- healthy volunteers, paroxetine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2008 (actual)
- Primary completion
- 16 Sep 2008 (actual)
- Study completion
- 16 Sep 2008 (actual)
- First posted
- 9 Sep 2008 (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.
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label treatment | Experimental | Drug: Paxil CROn each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.
Key exclusion criteria (1 listed)
- Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; >14 drinks/week for men or >7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.
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 |
|---|---|---|
| Paxil CRPaxil CR 37mg tablet manufactures at two different sites | Drug | open label treatment |
Primary outcome
Paroxetine blood levels
Time frame: measured up to 168 hours after a single dose.
1 secondary outcome
Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs
Time frame: measured up to 168 hours after a single dose and throughout study
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 4 Aug 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study PCR111656 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Survivorship
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paxil CR in people with Depressive Disorder, run by GlaxoSmithKline at 2 sites in United States.
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 1 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Paroxetine blood levels (time frame: measured up to 168 hours after a single dose.). 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 4 Aug 2017.