clinical trial · NCT00841698
Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 50
HealthyParoxetine HClPaxil®
brief summary
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) versus Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fasting conditions.
started
Oct 1, 2002
primary completion
Oct 1, 2002
completion
Oct 1, 2002
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
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 Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol