Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
This study has been completed.
Sponsor:
Dr. Reddy's Laboratories Limited
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01064271
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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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 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 ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Senior Director - Research & Development, Dr. Reddy's Laboratories Limited |
| ClinicalTrials.gov Identifier: | NCT01064271 History of Changes |
| Other Study ID Numbers: | 10640602 |
| Study First Received: | February 4, 2010 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 21, 2013