Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829673
First received: January 26, 2009
Last updated: August 14, 2009
Last verified: August 2009

January 26, 2009
August 14, 2009
June 2004
June 2004   (final data collection date for primary outcome measure)
  • Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829673 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Dexmethylphenidate Hydrochloride Tablets Under Non-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 an Equivalent Dose of a Commercially Available Reference Product (Focalin®, Novartis Pharmaceuticals Corporation) in 24 Fed, Healthy, Adult Subjects

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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Dexmethylphenidate Hydrochloride
    10 mg Tablet
  • Drug: Dexmethylphenidate Hydrochloride
    10 mg Tablet
    Other Name: Focalin®
  • Experimental: 1
    Intervention: Drug: Dexmethylphenidate Hydrochloride
  • Active Comparator: 2
    Focalin®
    Intervention: Drug: Dexmethylphenidate Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Sex: Male and Female; similar proportion of each preferred.
  2. Age: At least 18 years.
  3. Weight: BMI (Body Mass Index) less than or equal to 30.
  4. Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subjects may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:

    • Laboratory Tests: Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin,m creatinine, AST, ALT, LD, alkaline phosphatase and urinalysis. HIV, Hepatitis B, Hepatitis C, breath alcohol test, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing and breath alcohol testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in.

    Laboratory values which are greater than ±20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.

    • Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
  5. Subjects must read and sign the Consent Form.

Exclusion Criteria

  1. Subjects not complying with the above inclusion criteria must be excluded from the study.
  2. In addition, any one of the conditions listed below will exclude a subject from the study:

    • History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
    • History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
    • History of GERD (gastroesophageal reflux disease), stricture of the esophagus, achalasia, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
    • History of upper gastrointestinal disorder such as dysphagia, esophagitis, gastritis, ulcers.
    • History of treatment for asthma within the past five (5) years.
    • History of marked treatable anxiety, tension, agitation.
    • History of glaucoma
    • History of motor tics
    • Family history or diagnosis of tourettes syndrome
    • History of treatment with monoamine oxidase inhibitors
    • History of seizures
    • Inability to sit upright for a period of at least 30 minutes
    • Females who are pregnant or lactating
    • History of hypersensitivity to dexmethylphenidate hydrochloride, methylphenidate or any central nervous system stimulant
  3. Conditions upon screening which might contraindicate or require that caution be used in the administration of dexmethylphenidate hydrochloride, including:

    • Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.
    • Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
  4. Inability to read and/or sign the consent form.
  5. Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
  6. Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
  7. Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.). Three (3) months abstinence is required.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829673
04163
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Irwin Plisco, M.D. Cetero Research, San Antonio
Teva Pharmaceuticals USA
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP