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

NCT01064232 | Completed Phase 1

• 1 other identifier: 10640601
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  3-4 months

Study Arms (2)

Risperidone

EXPERIMENTAL

Risperidone Tablets 1 mg of Dr Reddys Laboratories Limited

Drug: Risperidone

Risperdal

ACTIVE COMPARATOR

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

Drug: Risperidone

Interventions

Risperidone DRUG

Risperidone Tablets 1 mg

Also known as: Risperdal® Tablets, 1 mg

Risperdal; Risperidone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Soran Hong, MD

  Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Honston, Texas 77042-4712, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: October 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 8, 2010

Record last verified: 2010-02