Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT01222975
First received: October 15, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fasted conditions.


Condition Intervention
Healthy
Drug: Risperidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single Dose Two-way Crossover Fasted Bioequivalence Study of Risperidone 1 mg ODT Tablets in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence evaluation of Risperidone 1 mg Orally-disintegrating tablets [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2004
Study Completion Date: December 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Risperidone orally disintegrating tablets of Ranbaxy Laboratories, Ltd
Drug: Risperidone
orally disintegrating tablets
Active Comparator: 2
Risperdal® M-Tab of Janssen Pharmaceutica Products L.P.
Drug: Risperidone
orally disintegrating tablets

Detailed Description:

A single dose two way crossover bioequivalence study in 44 normal healthy males and females was utilized to evaluate the pharmacokinetics and bioequivalence of Risperidone ODT (orally dissolving tablet) formulations. The test product was a 1 mg ODT tablet formulation of Risperidone manufactured by Ranbaxy Laboratories Ltd. The reference product was commercially available Risperidone 1 mg ODT tablets (Risperdal®), Janssen Pharmaceutica Products, LP. Each single oral dose (1 mg) will be administered orally as a 1 mg tablet. Blood samples were collected at intervals over a 72-hour period after medication administration. There was a washout period of 14 days between the two periods of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subjects at least 18 years of age
  2. Informed of the nature of the study and given written informed consent
  3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables weighing at least 110 pounds

Exclusion Criteria:

  1. Hypersensitivity to risperidone (Risperdal®)
  2. Any history of a clinical condition that might affect drug absorption, metabolism or excretion
  3. Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism
  4. Donation of greater than 500 mg of blood in the past 4 weeks prior to study dosing or difficulty in donating blood
  5. Received an investigational drug within the 4 weeks prior to study dosing
  6. Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to the study dosing or over the counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician
  7. Regular smoking or more than 5 cigarettes daily or the daily use of nicotine-containing products beginning 3 months before the study medication administration through the final evaluation
  8. If female the subject is lactating or has a positive pregnancy test at screening and prior to each of the treatment periods. Females of child-bearing potential must use a medically acceptable method of contraception throughout the study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/ or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication
  9. Alcohol, grapefruit beverages or foods or caffeine beverages or foods beginning 1 days before each study medication administration through each study confinement period. Such restricted items include coffee, tea, iced tea, coke®, Pepsi®, mountain dew®, chocolate, brownies, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222975

Locations
United States, North Carolina
aaiPharma Inc.
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT01222975     History of Changes
Other Study ID Numbers: AAI-US-257
Study First Received: October 15, 2010
Last Updated: October 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
risperidone fasting study

Additional relevant MeSH terms:
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 20, 2014