Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829712
First received: January 26, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Dexmethylphenidate Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: June 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dexmethylphenidate Hydrochloride
10 mg Tablet
Active Comparator: 2
Focalin®
Drug: Dexmethylphenidate Hydrochloride
10 mg Tablet
Other Name: Focalin®

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829712

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Irwin Plisco, M.D. Cetero Research, San Antonio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00829712     History of Changes
Other Study ID Numbers: 04162
Study First Received: January 26, 2009
Results First Received: June 22, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014