Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Risperidone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited Official(s) and/or principal investigator(s): Evin H Sides III,, MD, Principal Investigator, Affiliation: AAIPharma
Summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of
Risperidone formulations after administration of single doses to normal, healthy subjects
under fed conditions.
Clinical Details
Official title: Single Dose Two-way Crossover Fed Bioequivalence Study of Risperidone 1 mg ODT Tablets in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence evaluation of risperidone 1 mg ODT tablets
Detailed description:
A single dose two way crossover bioequivalence study in 40 normal healthy males and females
was utilized to evaluate the pharmacokinetics and bioequivalence of Risperidone ODT (orally
dissolving tablet) formulations. The test product was a 1 mg ODT tablet formulation of
Risperidone manufactured by Ranbaxy Laboratories Ltd. The reference product was commercially
available Risperidone 1 mg ODT tablets (Risperdal®), Janssen Pharmaceutica Products, LP.
Each single oral dose (1 mg) will be administered orally as a 1 mg tablet. Blood samples
were collected at intervals over a 72-hour period after medication administration. There was
a washout period of 14 days between the two periods of the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy subjects at least 18 years of age
2. Informed of the nature of the study and given written informed consent
3. Have a body weight within 15% of the appropriate range as defined in the 1983
Metropolitan Life Company tables weighing at least 110 pounds
Exclusion Criteria:
1. Hypersensitivity to risperidone (Risperdal®)
2. Any history of a clinical condition that might affect drug absorption, metabolism or
excretion
3. Recent history (within one year) of mental illness, drug addiction, drug abuse or
alcoholism
4. Donation of greater than 500 mg of blood in the past 4 weeks prior to study dosing or
difficulty in donating blood
5. Received an investigational drug within the 4 weeks prior to study dosing
6. Currently taking any prescription medication, except for oral contraceptives, within
the 7 days prior to the study dosing or over the counter medication within 3 days of
study dosing. This prohibition does not include vitamins or herbal preparations taken
as nutritional supplements for non-therapeutic indications as judged by the attending
physician
7. Regular smoking or more than 5 cigarettes daily or the daily use of
nicotine-containing products beginning 3 months before the study medication
administration through the final evaluation
8. If female the subject is lactating or has a positive pregnancy test at screening and
prior to each of the treatment periods. Females of child-bearing potential must use a
medically acceptable method of contraception throughout the study period and for one
week after the study is completed. Medically acceptable methods of contraception that
may be used by the subject and/ or her partner are: oral contraceptives, progestin
injection or implants, condom with spermicide, diaphragm with spermicide, IUD,
vaginal spermicidal suppository, surgical sterilization of their partner(s) or
abstinence. Females taking oral contraceptives must have taken them consistently for
at least three months prior to receiving study medication
9. Alcohol, grapefruit beverages or foods or caffeine beverages or foods beginning 1
days before each study medication administration through each study confinement
period. Such restricted items include coffee, tea, iced tea, coke®, Pepsi®, mountain
dew®, chocolate, brownies, etc.
Locations and Contacts
aaiPharma Inc., Chapel Hill, North Carolina 27517, United States
Additional Information
Starting date: October 2004
Last updated: October 15, 2010
|