HealthyPhase 1NCT02012049
Bioequivalence Test for Risperdal 2mg of Janssen Korea
A Phase 1 study testing Risperdal OD Tab. 2mg and Risperdal Quicklet Tab. 2mg in people with Healthy, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Risperdal OD Tab. 2mg and Risperdal Quicklet Tab. 2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2009
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Korean participants weighing more than 50kg and within 20% normal lean body weight (standard weight)
- Participant without congenital or chronic diseases and with no symptoms or findings as a result of internal examination
- Participant who was deemed appropriate as a result of inquiry, blood pressure, physical examination, electrocardiogram, blood and urinalysis, etc., within 28 days prior to the first administration of the investigational drug according to the protocol
- Female participant who was confirmed as non-pregnant through urine test during health examination
Who cannot join
- Participant who had a history of disease related to cardiac, respiratory, hepatic, renal, gastrointestinal or nervous system, or cardiac infarction, stroke, hypertension, arrhythmia, coronary artery disease, or neuropsychiatric diseases that could affect drug absorption, distribution, metabolism and excretion or could be risk factors when taking drugs used for the clinical trial, a history of gastrointestinal surgery except appendectomy or herniotomy, or who currently had abnormality in inquiry or physical examination
- Participant who showed symptoms that were suspected as acute disease within 14 days from the first administration of the investigational drug
- Participant with allergic disease requiring treatment
- Participant who had a history of being hypersensitive to drugs or food
- Patient who had hepatitis B antigen or who showed hepatitis C positive antigen
About this study
Official title: Bioequivalence Test for Risperdal OD Tab. 2mg of Janssen Korea
The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.
Read the detailed description
This was a randomized (the study drug is assigned by chance) and open labeled (all people know the identity of the intervention) study. All participants were hospitalized in research rooms and were subsequently restricted in exercise, eating, drinking, smoking and xanthine-beverages until the end of blood collection. Water was allowed to be taken until one hour before drug administration. Participants were randomly assigned into two groups, one group receiving Risperdal OD (investigational drug), and one group receiving Risperdal Quicklet (control drug). On the day of testing, blood was collected from all participants to provide baseline measurements. Subsequently, the study drug was orally administered to the participants, followed by blood collection of a total of 13 time points, up to 24 hours. After the blood collection was finished, participants were discharged after receiving proper guidance and being examined by a psychologist. Following a wash-out period (period when receiving no intervention) of one week, participants were hospitalized once more and crossed over to receive the study drugs following the same procedure above described. The approximate study duration (including the drug administration days and wash-out period) was approximately 10 days.
- Conditions
- Healthy
- Being tested
- Risperdal OD Tab. 2mg, Risperdal Quicklet Tab. 2mg
- Keywords
- Healthy, Risperdal OD, Risperdal Quicklet, Korea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperdal OD Tab. 2mgDrug
1 tablet Risperdal OD 2 mg administered orally.
Risperdal Quicklet Tab. 2mgDrug
1 tablet Risperdal Quicklet Tab. 2mg administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Risperdal OD / Risperdal Quicklet | Experimental | Risperdal OD (investigational drug) + Risperdal Quicklet (control drug) Receives: Drug: Risperdal OD Tab. 2mg; Drug: Risperdal Quicklet Tab. 2mg |
| Risperdal Quicklet / Risperdal OD | Experimental | Risperdal Quicklet (control drug) + Risperdal OD (investigational drug) Receives: Drug: Risperdal OD Tab. 2mg; Drug: Risperdal Quicklet Tab. 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of Risperidone
Measured: Up to 24 hours postdose
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety
Measured: Approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionAug 2009
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012049
- Sponsor's protocol ID
- CR016576
- Other IDs
- RISSCH1015, RIS-KOR-1083
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Test for Risperdal OD Tab. 2mg of Janssen Korea
- ClinicalTrials.gov ID
- NCT02012049
- Acronym / sponsor ID
- CR016576
- Conditions
- Healthy
- Keywords
- Healthy, Risperdal OD, Risperdal Quicklet, Korea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Dec 2013 (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 was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.
Detailed description
This was a randomized (the study drug is assigned by chance) and open labeled (all people know the identity of the intervention) study. All participants were hospitalized in research rooms and were subsequently restricted in exercise, eating, drinking, smoking and xanthine-beverages until the end of blood collection. Water was allowed to be taken until one hour before drug administration. Participants were randomly assigned into two groups, one group receiving Risperdal OD (investigational drug), and one group receiving Risperdal Quicklet (control drug). On the day of testing, blood was collected from all participants to provide baseline measurements. Subsequently, the study drug was orally administered to the participants, followed by blood collection of a total of 13 time points, up to 24 hours. After the blood collection was finished, participants were discharged after receiving proper guidance and being examined by a psychologist. Following a wash-out period (period when receiving no intervention) of one week, participants were hospitalized once more and crossed over to receive the study drugs following the same procedure above described. The approximate study duration (including the drug administration days and wash-out period) was approximately 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperdal OD / Risperdal Quicklet | Experimental | Drug: Risperdal OD Tab. 2mg, Drug: Risperdal Quicklet Tab. 2mgRisperdal OD (investigational drug) + Risperdal Quicklet (control drug) |
| Risperdal Quicklet / Risperdal OD | Experimental | Drug: Risperdal OD Tab. 2mg, Drug: Risperdal Quicklet Tab. 2mgRisperdal Quicklet (control drug) + Risperdal OD (investigational drug) |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Korean participants weighing more than 50kg and within 20% normal lean body weight (standard weight)
- Participant without congenital or chronic diseases and with no symptoms or findings as a result of internal examination
- Participant who was deemed appropriate as a result of inquiry, blood pressure, physical examination, electrocardiogram, blood and urinalysis, etc., within 28 days prior to the first administration of the investigational drug according to the protocol
- Female participant who was confirmed as non-pregnant through urine test during health examination
Key exclusion criteria (5 listed)
- Participant who had a history of disease related to cardiac, respiratory, hepatic, renal, gastrointestinal or nervous system, or cardiac infarction, stroke, hypertension, arrhythmia, coronary artery disease, or neuropsychiatric diseases that could affect drug absorption, distribution, metabolism and excretion or could be risk factors when taking drugs used for the clinical trial, a history of gastrointestinal surgery except appendectomy or herniotomy, or who currently had abnormality in inquiry or physical examination
- Participant who showed symptoms that were suspected as acute disease within 14 days from the first administration of the investigational drug
- Participant with allergic disease requiring treatment
- Participant who had a history of being hypersensitive to drugs or food
- Patient who had hepatitis B antigen or who showed hepatitis C positive antigen
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 |
|---|---|---|
| Risperdal OD Tab. 2mg1 tablet Risperdal OD 2 mg administered orally. | Drug | Risperdal OD / Risperdal Quicklet, Risperdal Quicklet / Risperdal OD |
| Risperdal Quicklet Tab. 2mg1 tablet Risperdal Quicklet Tab. 2mg administered orally. | Drug | Risperdal OD / Risperdal Quicklet, Risperdal Quicklet / Risperdal OD |
Primary outcome
Plasma concentrations of Risperidone
Time frame: Up to 24 hours postdose
1 secondary outcome
Number of participants with adverse events as a measure of safety
Time frame: Approximately 10 days
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 16 Dec 2013.
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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.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Risperdal OD Tab. 2mg and Risperdal Quicklet Tab. 2mg in people with Healthy, run by Janssen Korea, Ltd., Korea.
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 4 inclusion and 5 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 16 Dec 2013. 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?
Plasma concentrations of Risperidone (time frame: Up to 24 hours postdose). 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 16 Dec 2013.