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
Sponsor study identifier
interventional
24
1 country
1
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2004
Actual (reported)Study Completion
June 2004
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2004
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
June 2004
Actual (reported)June 2004
Actual (reported)January 26, 2009
Actual (reported)January 27, 2009
Actual (reported)August 4, 2009
Actual (reported)Cmax (Maximum Observed Concentration)
Bioequivalence based on Cmax.
Blood samples collected over a 16 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Blood samples collected over a 16 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Blood samples collected over a 16 hour period.
Focalin®
10 mg Tablet
10 mg Tablet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gateway Medical Research, Inc.
Saint Charles, Missouri, 63301, United States
Irwin Plisco, M.D.
Cetero Research, San Antonio
24 participants (actual enrollment reported by the registry).
First Submitted
January 26, 2009
First Posted
January 27, 2009
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
Contact the study team to confirm eligibility.
Primary Completion
June 2004
Actual (reported)Study Completion
June 2004
Actual (reported)Last Updated
August 19, 2024
Results First Posted
August 4, 2009
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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