HealthyNCT01222975
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fasting Conditions
A study testing Risperidone in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Two-way Crossover Fasted Bioequivalence Study of Risperidone 1 mg ODT Tablets in Healthy Volunteers
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.
Read the detailed description
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
- Healthy
- Being tested
- Risperidone
- Keywords
- risperidone fasting study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
orally disintegrating tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Risperidone orally disintegrating tablets of Ranbaxy Laboratories, Ltd Receives: Drug: Risperidone |
| 2 | Active comparator | Risperdal® M-Tab of Janssen Pharmaceutica Products L.P. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence evaluation of Risperidone 1 mg Orally-disintegrating tablets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2004
- Primary completionOct 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222975
- Sponsor's protocol ID
- AAI-US-257
- Status last verified
- Oct 2010
- First submitted
- 15 Oct 2010
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Two-way Crossover Fasted Bioequivalence Study of Risperidone 1 mg ODT Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01222975
- Acronym / sponsor ID
- AAI-US-257
- Conditions
- Healthy
- Keywords
- risperidone fasting study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RisperidoneRisperidone orally disintegrating tablets of Ranbaxy Laboratories, Ltd |
| 2 | Active comparator | Drug: RisperidoneRisperdal® M-Tab of Janssen Pharmaceutica Products L.P. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidoneorally disintegrating tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence evaluation of Risperidone 1 mg Orally-disintegrating tablets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence evaluation of Risperidone 1 mg Orally-disintegrating tablets. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2010.