Risperidone 1 mg Tablet in Healthy Subjects Under Fasting Conditions

NCT00830349 | Completed Phase 1

• 1 other identifier: 01172
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 tablet under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC

  2 weeks

Study Arms (2)

1

EXPERIMENTAL

Risperidone 1 mg Tablets

Drug: Risperidone

2

ACTIVE COMPARATOR

Risperdal® 1 mg Tablets

Drug: Risperidone

Interventions

Risperidone DRUG

1 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:

• 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 procedure.
• 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.

You may not qualify if:

• 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 medication.
• 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%).

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Benoit Girard, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

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, 2001
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2004
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CA (1)