Paxil CR Bioequivalence Study Brazil - Fed Administration

NCT01339247 | Completed Phase 1 Results

• 1 other identifier: 114035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Depressive Disorder

Keywords

Bioequivalence; Paroxetine reference/test; healthy volunteers; Fed condition

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Study Arms (2)

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

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

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

Interventions

Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico DRUG

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 Reference; Paxil CR Test

Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada DRUG

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

Paxil CR Reference; Paxil CR Test

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Belo Horizonte, Minas Gerais, 30110-014, Brazil

Location

Related Links

• Results for study 114035 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Depressive Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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 31, 2010
• First Posted: April 20, 2011
• Study Start: October 20, 2009
• Primary Completion: November 16, 2009
• Study Completion: November 16, 2009
• Last Updated: June 20, 2018
• Results First Posted: April 20, 2011

Record last verified: 2018-06

Locations

BR (1)