Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions

NCT00829673 | Completed Phase 1 Results

• 1 other identifier: 04163
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: Dexmethylphenidate Hydrochloride

2

ACTIVE COMPARATOR

Focalin®

Drug: Dexmethylphenidate Hydrochloride

Interventions

Dexmethylphenidate Hydrochloride DRUG

10 mg Tablet

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: Male and Female; similar proportion of each preferred.
• Age: At least 18 years.
• Weight: BMI (Body Mass Index) less than or equal to 30.
• 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.
• Subjects must read and sign the Consent Form.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Dexmethylphenidate Hydrochloride

Intervention Hierarchy (Ancestors)

Methylphenidate; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Irwin Plisco, M.D.

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: June 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: August 19, 2024
• Results First Posted: August 4, 2009

Record last verified: 2024-08

Locations

US (1)