clinical trial · NCT00834197
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
Teva Pharmaceuticals USA·phase1·completed·n = 32
HealthyMirtazapine 15 mg (Orally Disintegrating) TabletsREMERON SolTab® 15 mg Orally Disintegrating Tablets
brief summary
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under non-fasting conditions.
started
Jul 1, 2003
primary completion
Aug 1, 2003
completion
Aug 1, 2003
last updated
Aug 20, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Non-Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol