Paxil CR Bioequivalence Study Brazil - Fed Administration
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder; Healthy Volunteers
Intervention: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (Drug); Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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).
Clinical Details
Official title: Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablets With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fed Administration in Healthy Volunteers of Both Genders
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: AUC_ssCmin_ss Cmax_ss
Detailed description:
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), fed administration in healthy volunteers of both
genders.
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).
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 no
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 drug concentration 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 period after standardized meals. 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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Belo Horizonte, Minas Gerais 30110-014, Brazil
Additional Information
Starting date: October 2009
Last updated: May 5, 2011
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