NCT00829712

Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dexmethylphenidate Hydrochloride	10 mg Tablet
DRUG	Dexmethylphenidate Hydrochloride	10 mg Tablet

Timeline

• Start date: 2004-06-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2009-01-27
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: United States