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Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Risperidone (Drug); Risperidone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Benoit Girard, MD, Principal Investigator, Affiliation: Anapharm


The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.

Clinical Details

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal® 1 mg Tablets Administered as a 1 x 1 mg Tablets in Subjects Under Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Bioequivalence based on Cmax and AUC

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- Subjects will be females and/or males, non-smokers, 18 years of age and older.

- Subjects should read, sign and date an Informed Consent Form prior to any study


- Female Subjects will be post-menopausal or surgically sterilezed.

- Post-menopausal status is defined as absence of menses for the past 12 months,

- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation

at least 6 months ago. Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study:

- Clinically significant illnesses within 4 weeks of the administration of study


- Clinically significant surgery within 4 weeks prior to the administration of the

study medication.

- Any history or presence of significant Neurological, hepatic, renal, endocrine,

cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

- Any clinically significant abnormality found during medical screening.

- Any reason which, in the opinion of the medical subinvestigator, would prevent the

subject from participating in the study.

- Abnormal laboratory tests judged clinically significant.

- Subjects who do not tolerate venipuncture.

- Positive urine drug screen at screening.

- Subjects who use tobacco in any form will not be eligible to participate in this

study. Three months abstinence before screening is required.

- Positive testing for hepatitis B, hepatitis C or HIV at screening.

- ECG abnormalities (clinically significant) (PR interval greater than 225 msec or QTc

segment greater than 450 msec) or vital sign abnormalities (systolic blood pressure lower than 100 or over 160 mmHg, or diastolic blood pressure lower than 60 or over 96; or heart rate less than 60 bpm) at screening.

- Subjects with BMI ≥30. 0.

- History of seizures or other predisposing factors.

- History of significant alcohol abuse within six months of the screening visit or any

indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).

- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana,

pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.

- History of cardiac disease or family history of cardiac disease.

- Any food allergy, intolerance, restriction or special diet that, in the opinion of

the medical subinvestigator, contraindicates the subject's participation in this study.

- History of allergic reactions to risperidone.

- Use of any drugs known to induce or inhibit hepatic drug metabolism, use of an

investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.

- Use of prescription medication within 14 days prior to administration of study

medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.

- Donation of plasma (500 mL) within 7 days or donation or significant loss of whole

blood (500 mL) within 56 days prior to administration of the study medication.

- Positive alcohol breath test at screening.

Additional exclusion criteria for female subjects only: o Positive urine pregnancy test at screening (performed on all females).

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec G1V 2K8, Canada
Additional Information

Starting date: June 2001
Last updated: January 26, 2009

Page last updated: August 23, 2015

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