NCT01316926

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2009

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 18, 2011

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

26 days

First QC Date

August 30, 2010

Results QC Date

March 24, 2011

Last Update Submit

June 18, 2018

Conditions

Depressive Disorder

Keywords

fast conditionParoxetine reference/testhealthy volunteersBioequivalence

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

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

Study Arms (2)

Paxil CR Reference

ACTIVE COMPARATOR

Reference drug administration followed by test drug administration

Drug: Test formulationDrug: Reference formulation

Paxil CR Test

ACTIVE COMPARATOR

Test drug administration followed by Reference drug administration

Drug: Test formulationDrug: Reference formulation

Interventions

Test formulationDRUG

Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)

Paxil CR ReferencePaxil CR Test
Reference formulationDRUG

Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

Paxil CR ReferencePaxil CR Test

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Belo Horizonte, Minas Gerais, 30110-014, Brazil

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Limitations and Caveats

The number of adverse events per intervention is not available in the final report.

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2010

First Posted

March 16, 2011

Study Start

September 9, 2009

Primary Completion

October 5, 2009

Study Completion

October 5, 2009

Last Updated

June 20, 2018

Results First Posted

April 18, 2011

Record last verified: 2018-06

Locations

BR(1)