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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Risperidone

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males and females, 18 - 55 years of age.
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.
A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

If female, pregnant, lactating or likely to become pregnant during the study.
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.
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
Presence of a medical condition requiring regular treatment with prescription drugs.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
Receipt of any drug as part of a research study within 30 days prior to dosing.
Drug or alcohol addiction requiring treatment in the past 12 months.
Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Positive test results for drugs of abuse at screening.
Positive serum pregnancy test.
Subjects who smoke more than 10 cigarettes/day or equivalent tobacco use.
Subjects who have been on a special diet during the 28 days prior to dosing
Subjects who consume on average more than 3 units of alcohol/day.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Risperidone

Risperdal®

Arm Description

Risperidone Tablets 1 mg of Dr Reddys Laboratories Limited

Risperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P

Outcomes

Primary Outcome Measures

Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg

Secondary Outcome Measures

Full Information

NCT ID

NCT01064271

First Posted

February 4, 2010

Last Updated

February 4, 2010

Sponsor

Dr. Reddy's Laboratories Limited

1. Study Identification

Unique Protocol Identification Number

NCT01064271

Brief Title

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

Official Title

A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fed Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dr. Reddy's Laboratories Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A Single-dose, Randomized, two-Period, Cross over Study

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Risperidone

Arm Type

Experimental

Arm Description

Risperidone Tablets 1 mg of Dr Reddys Laboratories Limited

Arm Title

Risperdal®

Arm Type

Active Comparator

Arm Description

Risperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P

Intervention Type

Drug

Intervention Name(s)

Risperidone

Other Intervention Name(s)

Risperdal® Tablets, 1 mg

Intervention Description

Risperidone Tablets 1 mg

Primary Outcome Measure Information:

Title

Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg

Time Frame

3-4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females, 18 - 55 years of age. 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. A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Signed and dated informed consent form, which meets all criteria of current FDA regulations. Exclusion Criteria: If female, pregnant, lactating or likely to become pregnant during the study. 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. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. Presence of gastrointestinal disease or history of malabsorption within the last year. History of psychiatric disorders occurring within the last two years that required hospitalization or medication. Presence of a medical condition requiring regular treatment with prescription drugs. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing. Receipt of any drug as part of a research study within 30 days prior to dosing. Drug or alcohol addiction requiring treatment in the past 12 months. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody. Positive test results for drugs of abuse at screening. Positive serum pregnancy test. Subjects who smoke more than 10 cigarettes/day or equivalent tobacco use. Subjects who have been on a special diet during the 28 days prior to dosing Subjects who consume on average more than 3 units of alcohol/day.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shirley Ann Kennedy, MD

Organizational Affiliation

Novum Pharmaceutical Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206-3817

Official's Role

Principal Investigator

12. IPD Sharing Statement

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

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