CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Paroxetine HCl +1 moredrug
Likely dose
Paroxetine HCl 40 mg film-coated tablet (single dose) or Paxil® 40 mg film-coated tablet (single dose)AI-extracted
Key inclusion· 4
  • ✓Age 18 years or older
  • ✓Non-smoking status
  • ✓Female subjects must be post-menopausal (no menses for ≥12 months) or surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation ≥6 months prior)
  • ✓Healthy volunteers acceptable for bioequivalence study
Key exclusion· 21
  • ✕Any clinically significant illness within 4 weeks of study drug administration
  • ✕Clinically significant surgery within 4 weeks prior to study drug
  • ✕History of renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma
  • ✕History of seizures or mania

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00841659
NCT00841659Phase 1Completed
CompareCT.gov

Randomized, 2-Way Crossover, Bioequivalence Study of Paroxetine Hydrochloride 40 mg Film-Coated Tablets and Paxil® 40 mg Film-Coated Tablets Administered as 1 x 40 mg Film-Coated Tablet in Healthy Subjects Under Fed Conditions

Teva Pharmaceuticals USA·interventional·Posted Feb 11, 2009·Updated Aug 19, 2024

In Brief

A Phase 1 clinical trial evaluating Paroxetine HCl and Paxil® for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) and Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2009
Enrollment StartAug 1, 2002
Primary CompletionAug 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Paroxetine HCldrug

40 mg Film-Coated Tablet

Paxil®drug

40 mg Film-Coated Tablet