clinical trial · NCT00829712
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 24
HealthyDexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride
brief summary
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate hydrochloride in a test population of 24 adult subjects under fasted conditions.
started
Jun 1, 2004
primary completion
Jun 1, 2004
completion
Jun 1, 2004
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Dexmethylphenidate Hydrochloride, (10 mg), Compared to and Equivalent Dose of a Commercially Available Reference Drug Product (Focalin®, Novartis Pharmaceuticals Corporation) in 24 Fasted, Healthy, Adult Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol