HealthyPhase 1NCT01064232
Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
A Phase 1 study testing Risperidone in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
A Single-dose, Randomized, two-Period, Cross over Study Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2006
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, 18 - 55 years of age.
- Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.
- A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
Who cannot join
- If female, pregnant, lactating or likely to become pregnant during the study.
- History of allergy or sensitivity to risperidone, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- Presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
- Presence of a medical condition requiring regular treatment with prescription drugs.
Show all 16Show fewer
- Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Drug or alcohol addiction requiring treatment in the past 12 months.
- Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
- Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test results for drugs of abuse at screening.
- Positive serum pregnancy test.
- Subjects who smoke more than 10 cigarettes/day or equivalent tobacco use.
- Subjects who have been on a special diet during the 28 days prior to dosing
- Subjects who consume on average more than 3 units of alcohol/day.
About this study
Official title: A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fasting Conditions
A Single-dose, Randomized, two-Period, Cross over Study
Read the detailed description
Randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions.
The test formulation was Dr. Reddy's Laboratories Limited's Risperidone Tablets, 1 mg, and the reference formulation was Risperdal® (risperidone) tablets, 1 mg (Janssen Pharmaceutica Products, L.P.).
The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was administered to all subjects following an overnight fast.The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
- Conditions
- Healthy
- Being tested
- Risperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal® Tablets, 1 mg
Risperidone Tablets 1 mg
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Experimental | Risperidone Tablets 1 mg of Dr Reddys Laboratories Limited Receives: Drug: Risperidone |
| Risperdal | Active comparator | Risperdal® Tablets, 1 mg 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.
Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startOct 2006
- Primary completionOct 2006
- Study completionOct 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Soran Hong, MD, Principal investigator, Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Honston, Texas 77042-4712, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064232
- Sponsor's protocol ID
- 10640601
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Two Risperidone 1 mg Tablet Formulations Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01064232
- Acronym / sponsor ID
- 10640601
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 8 Feb 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.
A Single-dose, Randomized, two-Period, Cross over Study
Detailed description
Randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions.
The test formulation was Dr. Reddy's Laboratories Limited's Risperidone Tablets, 1 mg, and the reference formulation was Risperdal® (risperidone) tablets, 1 mg (Janssen Pharmaceutica Products, L.P.).
The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was administered to all subjects following an overnight fast.The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Experimental | Drug: RisperidoneRisperidone Tablets 1 mg of Dr Reddys Laboratories Limited |
| Risperdal | Active comparator | Drug: RisperidoneRisperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females, 18 - 55 years of age.
- Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.
- A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
Key exclusion criteria (16 listed)
- If female, pregnant, lactating or likely to become pregnant during the study.
- History of allergy or sensitivity to risperidone, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- Presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
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 |
|---|---|---|
| RisperidoneAlso: Risperdal® Tablets, 1 mgRisperidone Tablets 1 mg | Drug | Risperdal, Risperidone |
Primary outcome
Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg
Time frame: 3-4 months
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 8 Feb 2010.
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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.
Soran Hong, MD principal investigator
Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Honston, Texas 77042-4712, USA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperidone in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 16 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg (time frame: 3-4 months). 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 8 Feb 2010.