Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions

NCT ID: NCT00829673

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2004-06-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Dexmethylphenidate Hydrochloride

Intervention Type: DRUG

10 mg Tablet

2

Focalin®

Group Type: ACTIVE_COMPARATOR

Dexmethylphenidate Hydrochloride

Intervention Type: DRUG

10 mg Tablet

Interventions

Dexmethylphenidate Hydrochloride

10 mg Tablet

Intervention Type: DRUG

Dexmethylphenidate Hydrochloride

10 mg Tablet

Intervention Type: DRUG

Other Intervention Names

Focalin®

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Irwin Plisco, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

04163

Identifier Type: -

Identifier Source: org_study_id