Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
Condition: Healthy
Intervention: Dexmethylphenidate Hydrochloride; Dexmethylphenidate Hydrochloride
Intervention description: 10 mg Tablet; 10 mg Tablet
Intervention MeSH terms: Dexmethylphenidate Hydrochloride
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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.
    

Eligibility 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.