HealthyPhase 1NCT00829894
Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
A Phase 1 study testing Risperidone in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed 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
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2001to Jul 2001
- Phase
- Phase 1
- 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
- Subjects will be females and/or males, non-smokers, 18 years of age and older.
- Subjects should read, sign and date an Informed Consent Form prior to any study procedure.
- Female Subjects will be post-menopausal or surgically sterilezed.
- Post-menopausal status is defined as absence of menses for the past 12 months,
- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any history or presence of significant Neurological, hepatic, renal, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
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- Abnormal laboratory tests judged clinically significant.
- Subjects who do not tolerate venipuncture.
- Positive urine drug screen at screening.
- Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence before screening is required.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
- ECG abnormalities (clinically significant) (PR interval greater than 225 msec or QTc segment greater than 450 msec) or vital sign abnormalities (systolic blood pressure lower than 100 or over 160 mmHg, or diastolic blood pressure lower than 60 or over 96; or heart rate less than 60 bpm) at screening.
- Subjects with BMI ≥30.0.
- History of seizures or other predisposing factors.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- History of cardiac disease or family history of cardiac disease.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
- History of allergic reactions to risperidone.
- Use of any drugs known to induce or inhibit hepatic drug metabolism, use of an investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
- Positive alcohol breath test at screening.
- Additional exclusion criteria for female subjects only:
- o Positive urine pregnancy test at screening (performed on all females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal® 1 mg Tablets Administered as a 1 x 1 mg Tablets in Subjects Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Risperidone
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
1 mg Tablet
RisperidoneDrug
Also called Risperdal®
1 mg Tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Risperidone 1 mg Tablet Receives: Drug: Risperidone |
| 2 | Active comparator | Risperdal® 1 mg Tablet Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJun 2001
- Primary completionJul 2001
- Study completionJul 2001
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Benoit Girard, MD, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829894
- Sponsor's protocol ID
- 01173
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2009
- Last updated
- 19 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal® 1 mg Tablets Administered as a 1 x 1 mg Tablets in Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00829894
- Acronym / sponsor ID
- 01173
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 27 Jan 2009 (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 objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RisperidoneRisperidone 1 mg Tablet |
| 2 | Active comparator | Drug: RisperidoneRisperdal® 1 mg Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects will be females and/or males, non-smokers, 18 years of age and older.
- Subjects should read, sign and date an Informed Consent Form prior to any study procedure.
- Female Subjects will be post-menopausal or surgically sterilezed.
- Post-menopausal status is defined as absence of menses for the past 12 months,
- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
Key exclusion criteria (25 listed)
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any history or presence of significant Neurological, hepatic, renal, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
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 |
|---|---|---|
| Risperidone1 mg Tablet | Drug | 1 |
| RisperidoneAlso: Risperdal®1 mg Tablet | Drug | 2 |
Primary outcome
Bioequivalence based on Cmax and AUC
Time frame: 2 weeks
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 19 Aug 2024.
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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.
Benoit Girard, MD principal investigator
Anapharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperidone in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
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 5 inclusion and 25 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 19 Aug 2024. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 based on Cmax and AUC (time frame: 2 weeks). 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 19 Aug 2024.