Last updated: 11/03/2018 15:51:58

Paxil CR Bioequivalence Study Brazil

GSK study ID
113939
See study documents
Clinicaltrials.gov ID
NCT01316926
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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).
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Area Under the Curve_steady-state

Timeframe: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)

Cmin_steady-state

Timeframe: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)

Cmax_steady-state

Timeframe: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)

Secondary outcomes:
Not applicable
Interventions:
Drug: Test formulation
Drug: Reference formulation
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
2009-05-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
September 2009 to October 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
  • EXCLUSION CRITERIA:
  • hypersensitivity to the study drug or to compounds chemically related;
Inclusion and exclusion criteria
Inclusion criteria:
  • EXCLUSION CRITERIA:
  • 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. INCLUSION CRITERIA:
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30110-014
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2009-05-10
Actual study completion date
2009-05-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Results for study 113939 can be found on the GSK Clinical Study Register.
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Access to clinical trial data by researchers
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