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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01064232
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fasting 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 ] [ Designated as safety issue: No ]

Enrollment: 30
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-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions.

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

The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was administered to all subjects following an overnight fast.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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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: NCT01064232

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Soran Hong, MD Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Honston, Texas 77042-4712, USA
  More Information

No publications provided

Responsible Party: Senior Director - Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01064232     History of Changes
Other Study ID Numbers: 10640601
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014