Clinical trial NCT01064232: Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Official title: A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Single-dose, Randomized, two-Period, Cross over Study

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 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.

Primary outcomes:
measure: Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Honston, Texas 77042-4712, USA
name: Soran Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: