Phase 1 Completed N=60 Randomized Other

Paxil CR Bioequivalence Study Brazil - Fed Administration

Depressive Symptoms

Source: ClinicalTrials.gov NCT01339247 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2011

Primary outcomePrimary: AUC_ss — 672.9221; 645.5407 ng.h/ml

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY AUC_ss	672.9221; 645.5407	—
PRIMARY Cmin_ss	19.4468; 18.9010	—
PRIMARY Cmax_ss	36.7235; 36.6630	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01339247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.