NCT01222975

Brief 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 fasted conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2004

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

October 18, 2010

Status Verified

October 1, 2010

Enrollment Period

Same day

First QC Date

October 15, 2010

Last Update Submit

October 15, 2010

Conditions

Healthy

Keywords

risperidone fasting study

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence evaluation of Risperidone 1 mg Orally-disintegrating tablets

Study Arms (2)

1

EXPERIMENTAL

Risperidone orally disintegrating tablets of Ranbaxy Laboratories, Ltd

Drug: Risperidone

2

ACTIVE COMPARATOR

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

Drug: Risperidone

Interventions

RisperidoneDRUG

orally disintegrating tablets

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects at least 18 years of age
  • Informed of the nature of the study and given written informed consent
  • Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables weighing at least 110 pounds

You may not qualify if:

  • Hypersensitivity to risperidone (Risperdal®)
  • Any history of a clinical condition that might affect drug absorption, metabolism or excretion
  • Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism
  • Donation of greater than 500 mg of blood in the past 4 weeks prior to study dosing or difficulty in donating blood
  • Received an investigational drug within the 4 weeks prior to study dosing
  • 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
  • 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
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

aaiPharma Inc.

Chapel Hill, North Carolina, United States

Location

Related Links

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

October 1, 2004

Primary Completion

October 1, 2004

Study Completion

December 1, 2004

Last Updated

October 18, 2010

Record last verified: 2010-10

Locations

US(1)