Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
- Registration Number
- NCT00829673
- Lead Sponsor
- Teva Pharmaceuticals USA
- 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 (Focalin®, Novartis Pharmaceuticals Corporation) in a test population of 24 adult subjects under fed conditions.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Dexmethylphenidate Hydrochloride - 2 Dexmethylphenidate Hydrochloride Focalin®
- Primary Outcome Measures
Name Time Method Cmax (Maximum Observed Concentration) Blood samples collected over a 16 hour period. Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) Blood samples collected over a 16 hour period. Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) Blood samples collected over a 16 hour period. Bioequivalence based on AUC0-inf.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gateway Medical Research, Inc.
🇺🇸Saint Charles, Missouri, United States