MedDataX Logo

Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fasting Conditions

NCT ID: NCT01222975

Last Updated: 2010-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 fasted conditions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A single dose two way crossover bioequivalence study in 44 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Risperidone orally disintegrating tablets of Ranbaxy Laboratories, Ltd

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

orally disintegrating tablets

2

Risperdal® M-Tab of Janssen Pharmaceutica Products L.P.

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

orally disintegrating tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Risperidone

orally disintegrating tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ranbaxy Laboratories Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ranbaxy Research Laboratories

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

aaiPharma Inc.

Chapel Hill, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://clinicalstudies.ranbaxy.com

Related Info

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

http://www.fda.gov/opacom/7alerts.html

Related Info

http://www.fda.gov/Safety/Recalls/default.htm

Related Info

http://www.fda.gov/Safety/MedWatch/default.htm

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAI-US-257

Identifier Type: -

Identifier Source: org_study_id