Depressive DisorderPhase 1NCT01339247
Paxil CR Bioequivalence Study Brazil - Fed Administration
A Phase 1 study testing Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico and Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Brazil.
Trial summary
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico and Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2009to 16 Nov 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man and woman (since they are not pregnant or breastfeeding);
- age between 18 and 40 years;
- non-smoker and not addict;
- mass index between 18,5 and 27;
- good health conditions or without significant illness, by judgement of a legally qualified professional;
- sign the informed consent.
Who cannot join
- hypersensitivity to the study drug or to compounds chemically related;
- history of serious adverse events;
- concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
- History of liver, heart, gastrointestinal or renal illness;
- ECG findings not recommended according to the investigator judgement;
- The volunteer ingests more than 5 cups of coffee or tea a day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablets With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fed Administration in Healthy Volunteers of Both Genders
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).
Read the detailed description
Title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fed administration in healthy volunteers of both genders.
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration). The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are no restrictions regarding the ethnic group.
The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each period after standardized meals. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.
- Conditions
- Depressive Disorder
- Being tested
- Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
- Keywords
- Bioequivalence, Paroxetine reference/test, healthy volunteers, Fed condition
- 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 CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto RicoDrug
Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - CanadaDrug
Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
| Study group | Role | What they receive |
|---|---|---|
| Paxil CR Reference | Active comparator | Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 2 Receives: Drug: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico; Drug: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada |
| Paxil CR Test | Active comparator | Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 1, followed by Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 2 Receives: Drug: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico; Drug: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC_ss
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.
Measured: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)
Cmin_ss
Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
Measured: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)
Cmax_ss
Cmax_ss is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
Measured: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study start20 Oct 2009
- Primary completion16 Nov 2009
- Study completion16 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT01339247
- Sponsor's protocol ID
- 114035
- Status last verified
- Jun 2018
- First submitted
- 31 Aug 2010
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablets With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fed Administration in Healthy Volunteers of Both Genders
- ClinicalTrials.gov ID
- NCT01339247
- Acronym / sponsor ID
- 114035
- Conditions
- Depressive Disorder
- Keywords
- Bioequivalence, Paroxetine reference/test, healthy volunteers, Fed condition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2009 (actual)
- Primary completion
- 16 Nov 2009 (actual)
- Study completion
- 16 Nov 2009 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Posted 20 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).
Detailed description
Title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fed administration in healthy volunteers of both genders.
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration). The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are no restrictions regarding the ethnic group.
The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each period after standardized meals. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paxil CR Reference | Active comparator | Drug: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, Drug: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - CanadaParoxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 2 |
| Paxil CR Test | Active comparator | Drug: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, Drug: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - CanadaParoxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 1, followed by Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Man and woman (since they are not pregnant or breastfeeding);
- age between 18 and 40 years;
- non-smoker and not addict;
- mass index between 18,5 and 27;
- good health conditions or without significant illness, by judgement of a legally qualified professional;
Key exclusion criteria (6 listed)
- hypersensitivity to the study drug or to compounds chemically related;
- history of serious adverse events;
- concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
- History of liver, heart, gastrointestinal or renal illness;
- ECG findings not recommended according to the investigator judgement;
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 CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto RicoParoxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation) | Drug | Paxil CR Reference, Paxil CR Test |
| Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - CanadaParoxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) | Drug | Paxil CR Reference, Paxil CR Test |
Primary outcome
AUC_ss
Time frame: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.
Cmin_ss
Time frame: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)
Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
Cmax_ss
Time frame: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)
Cmax_ss is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results for study 114035 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 testing Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico and Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Brazil.
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 6 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 20 Jun 2018. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC_ss (time frame: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)). The study lists 3 primary outcomes in all. 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 20 Jun 2018; AzTrials last refreshed its copy on 1 Nov 2026.