Paxil CR Bioequivalence Study Brazil

Depressive Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316926
• Other study ID #: 113939
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2009
• Est. completion date: October 5, 2009

Study information

• Verified date: June 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2009
• Est. primary completion date: October 5, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)

External Links

•   Results for study 113939 can be found on the GSK Clinical Study Register.