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Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064271
First Posted: February 8, 2010
Last Update Posted: February 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dr. Reddy's Laboratories Limited
  Purpose
A Single-dose, Randomized, two-Period, Cross over Study

Condition Intervention Phase
Healthy Drug: Risperidone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg [ Time Frame: 3-4 months ]

Enrollment: 26
Study Start Date: October 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risperidone
Risperidone Tablets 1 mg of Dr Reddys Laboratories Limited
Drug: Risperidone
Risperidone Tablets 1 mg
Other Name: Risperdal® Tablets, 1 mg
Active Comparator: Risperdal®
Risperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P
Drug: Risperidone
Risperidone Tablets 1 mg
Other Name: Risperdal® Tablets, 1 mg

Detailed Description:

Randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two risperidone 1 mg tablet formulations under Fed conditions.

The test formulation was Dr. Reddy's Laboratories Limited's 1 mg Risperidone tablet, and the reference formulation was Risperdal® (risperidone) 1 mg tablet (Janssen Pharmaceutica Products, L.P.).

The study was conducted with 26 healthy adults. In each study period, a single 1 mg dose was administered to the subjects following a standardized high-fat breakfast preceded by an overnight fast of at least 10 hours.

The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females, 18 - 55 years of age.
  2. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.
  3. A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
  4. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
  5. Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

  1. If female, pregnant, lactating or likely to become pregnant during the study.
  2. History of allergy or sensitivity to risperidone, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
  3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
  4. Presence of gastrointestinal disease or history of malabsorption within the last year.
  5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
  6. Presence of a medical condition requiring regular treatment with prescription drugs.
  7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
  8. Receipt of any drug as part of a research study within 30 days prior to dosing.
  9. Drug or alcohol addiction requiring treatment in the past 12 months.
  10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
  11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  12. Positive test results for drugs of abuse at screening.
  13. Positive serum pregnancy test.
  14. Subjects who smoke more than 10 cigarettes/day or equivalent tobacco use.
  15. Subjects who have been on a special diet during the 28 days prior to dosing
  16. Subjects who consume on average more than 3 units of alcohol/day.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064271


Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Shirley Ann Kennedy, MD Novum Pharmaceutical Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206-3817
  More Information

Responsible Party: Senior Director - Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01064271     History of Changes
Other Study ID Numbers: 10640602
First Submitted: February 4, 2010
First Posted: February 8, 2010
Last Update Posted: February 8, 2010
Last Verified: February 2010

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