Paxil CR Bioequivalence Study Brazil

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01316926
First received: August 30, 2010
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention Phase
Depressive Disorder
Healthy Volunteers
Drug: Test formulation
Drug: Reference formulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Area Under the Curve_steady-state [ Time Frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paxil CR Reference
Reference drug administration followed by test drug administration
Drug: Test formulation
Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Drug: Reference formulation
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
Active Comparator: Paxil CR Test
Test drug administration followed by Reference drug administration
Drug: Test formulation
Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Drug: Reference formulation
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316926

Locations
Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30110-014
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01316926     History of Changes
Other Study ID Numbers: 113939
Study First Received: August 30, 2010
Results First Received: March 24, 2011
Last Updated: April 28, 2011
Health Authority: Brazil: Institutional Review Board
Brazil: ANVISA

Keywords provided by GlaxoSmithKline:
fast condition
Paroxetine reference/test
healthy volunteers
Bioequivalence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Halofantrine
Paroxetine
Anti-Infective Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014