Depressive DisorderPhase 1NCT01316926

Paxil CR Bioequivalence Study Brazil

A Phase 1 study testing Test formulation and Reference formulation in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Brazil.

Completed

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

Official record

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Trial summary

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). 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?: Test formulation and Reference formulation
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: 9 Sep 2009to 5 Oct 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.

Brazil1 site

GSK Investigational Site
Belo Horizonte, Minas Gerais, 30110-014

Other trials in Brazil

About this study

Official title: Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablet With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fasted Administration in Healthy Volunteers for 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).

Read the detailed description

Full 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), fasted administration in healthy volunteers for both genders.

The study is 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 not 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 concentration of drug 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 fasting period. 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: Test formulation, Reference formulation
Keywords: fast condition, Paroxetine reference/test, healthy volunteers, Bioequivalence
Medical subject headings: Depressive Disorder

What participants receive

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

Test formulationDrug
Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Reference formulationDrug
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

Study groups in NCT01316926
Study group	Role	What they receive
Paxil CR Reference	Active comparator	Reference drug administration followed by test drug administration Receives: Drug: Test formulation; Drug: Reference formulation
Paxil CR Test	Active comparator	Test drug administration followed by Reference drug administration Receives: Drug: Test formulation; Drug: Reference formulation

What is being measured

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

Area Under the Curve_steady-state
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_steady-state (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, nanogram; 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_steady-state
Cmin_steady-state (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_steady-state
Cmax_steady-state (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.

9 Sep 20095 Oct 2009

First posted16 Mar 2011 (estimated)
Study start9 Sep 2009
Primary completion5 Oct 2009
Study completion5 Oct 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01316926
Sponsor's protocol ID: 113939
Status last verified: Jun 2018
First submitted: 30 Aug 2010
Last updated: 20 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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All Depressive Disorder trials

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 Tablet With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fasted Administration in Healthy Volunteers for Both Genders.
ClinicalTrials.gov ID: NCT01316926
Acronym / sponsor ID: 113939
Conditions: Depressive Disorder
Keywords: fast condition, Paroxetine reference/test, healthy volunteers, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Sep 2009 (actual)
Primary completion: 5 Oct 2009 (actual)
Study completion: 5 Oct 2009 (actual)
First posted: 16 Mar 2011 (estimated)
Results: Posted 18 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 drug test and reference (two periods of drug administration).

Detailed description

The study is open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).

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: Test formulation, Drug: Reference formulationReference drug administration followed by test drug administration
Paxil CR Test	Active comparator	Drug: Test formulation, Drug: Reference formulationTest drug administration followed by Reference drug administration

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
Test formulationParoxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)	Drug	Paxil CR Reference, Paxil CR Test
Reference formulationParoxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)	Drug	Paxil CR Reference, Paxil CR Test

Primary outcome

Area Under the Curve_steady-state
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_steady-state (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, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.
Cmin_steady-state
Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Cmin_steady-state (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_steady-state
Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Cmax_steady-state (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

Results posted to the registry on 18 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product in Period 1; Reference Product in Period 2	30	30
Reference Product in Period 1; Test Product in Period 2	30	30

Primary outcome: Area Under the Curve_steady-state

Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2). Mean (Standard Deviation). Unit: ng/h/ml

Measure	Test Product n = 59	Reference Product n = 59
Value	996.2436 (546.1831)	1038.5812 (550.8923)

Test Product vs Reference Product: Ratio T formulation/R formulation: 0.9204 (90% CI 0.8556 to 0.9900)

Population analysed: Participants who completed the study

Primary outcome: Cmin_steady-state

Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2). Mean (Standard Deviation). Unit: ng/ml

Measure	Test Product n = 59	Reference Product n = 59
Value	26.4410 (15.7817)	27.9625 (15.8840)

Test Product vs Reference Product: Ratio T formulation/R formulation: 0.9410 (90% CI 0.8460 to 1.0467)

Population analysed: Participants who completed the study

Primary outcome: Cmax_steady-state

Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2). Mean (Standard Deviation). Unit: ng/ml

Measure	Test Product n = 59	Reference Product n = 59
Value	61.0319 (34.8551)	64.3281 (35.7439)

Test Product vs Reference Product: Ratio T formulation/R formulation: 0.9333 (90% CI 0.8502 to 1.0246)

Population analysed: Participants who completed the study

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1	0 of 60 (0%)	42 of 60 (70%)	Not reported
Period 2	0 of 59 (0%)	13 of 59 (22%)	Not reported

Limitations and caveats (from the sponsor): The number of adverse events per intervention is not available in the final report.

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 113939 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 Test formulation and Reference formulation 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 18 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?

Area Under the Curve_steady-state (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?

On the ClinicalTrials.gov record for NCT01316926.

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.