clinical trial · NCT00836667
Sertraline Hydrochloride 100 mg Tablets, Fed
Teva Pharmaceuticals USA·phase1·completed·n = 18
HealthyZoloft® 100 mg TabletsSertraline hydrochloride 100 mg Tablets
brief summary
The objective of this study is to compare the rate and extent of absorption of sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg tablet under fed conditions.
started
Mar 1, 2002
primary completion
Apr 1, 2002
completion
Apr 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 Sertraline Hydrochloride 100 mg Tablets and Zoloft® 100 mg Tablets Administered as 1 x 100 mg Tablet in Healthy Subjects Under Fed Conditions.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol