Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Risperidone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Shirley Ann Kennedy, MD, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206-3817
Summary
A Single-dose, Randomized, two-Period, Cross over Study
Clinical Details
Official title: A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fed Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bio-equivalence study of Dr Reddys Laboratories Risperidone 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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: October 2006
Last updated: February 4, 2010
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